Multiichallenge Nebulizer System
510(k) K883704
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK883704 | Date28 Nov 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- BTI
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.6250
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Multiichallenge Nebulizer System is a portable compressor device designed for delivering aerosolized medications. It is classified as a Class II medical device under FDA regulation 868.6250 and is intended for use in anesthesiology settings. This system generates fine mist particles to facilitate inhalation therapy, ensuring precise medication delivery to patients.
The device is supplied as a reusable system and is intended for use in clinical environments such as operating rooms or anesthesia suites. It operates on standard electrical power and requires no additional sterilization beyond routine cleaning per manufacturer guidelines. The Multiichallenge Nebulizer System holds an FDA 510(k) clearance (K883704) under the Traditional pathway, with a decision date of November 28, 1988. No MRI safety information or specific sterility assurances are provided in the available data.
Other devices from Biotrine Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Multiichallenge Nebulizer System used for?
The Multiichallenge Nebulizer System is designed for delivering aerosolized medications in anesthesiology settings. It generates fine mist particles to facilitate inhalation therapy, ensuring precise medication delivery to patients during procedures in operating rooms or anesthesia suites. This makes it particularly useful for administering anesthetics or other respiratory treatments where controlled aerosol administration is critical.
Is the Multiichallenge Nebulizer System reusable or single-use?
The Multiichallenge Nebulizer System is supplied as a reusable device. It is intended for use in clinical environments like operating rooms or anesthesia suites, where routine cleaning per manufacturer guidelines is sufficient. No additional sterilization beyond standard cleaning procedures is required, making it suitable for repeated use in controlled settings.
How is the Multiichallenge Nebulizer System powered and operated?
The device operates on standard electrical power, meaning it requires access to a typical electrical outlet for functionality. It does not require additional power sources, gas cylinders, or specialized connections, simplifying its setup in clinical environments. This portability and straightforward operation make it practical for use in anesthesia suites and operating rooms.
What are the key specifications or features of the Multiichallenge Nebulizer System?
The Multiichallenge Nebulizer System is classified as a Class II medical device under FDA regulation 868.6250 and holds an FDA 510(k) clearance (K883704) under the Traditional pathway, granted on November 28, 1988. It is a portable compressor designed specifically for anesthesiology applications, ensuring precise aerosolized medication delivery. The system does not include MRI safety information or specific sterility assurances in the available data.
What cleaning or maintenance procedures are recommended for the Multiichallenge Nebulizer System?
The manufacturer recommends routine cleaning as the primary maintenance procedure for the Multiichallenge Nebulizer System. No additional sterilization is required beyond standard cleaning, which helps maintain its functionality in clinical settings. Always follow the manufacturer’s guidelines to ensure proper hygiene and longevity of the device.