Oeco Apnea Monitor
by Oeco
510(k) K811628
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK811628 | Date31 Jul 1981 | 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- Withdrawn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
- BZQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.2375
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Oeco Apnea Monitor is a Monitor, Breathing Frequency device designed to continuously assess and display a patient’s respiratory rate. It provides real-time data on breathing patterns, enabling clinicians to identify and respond to respiratory abnormalities such as apnea or tachypnea. This device is intended for use in clinical settings where respiratory monitoring is critical, particularly in anesthesia and perioperative care.
The device is supplied as a reusable Class II medical instrument, regulated under 21 CFR 868.2375 and assigned FDA Product Code BZQ. It was cleared via a 510(k) Premarket Notification (K811628) and is classified under the Anesthesiology specialty. No specific sterility or MRI safety information is provided in the regulatory data. The device is intended for use in controlled clinical environments, adhering to standard infection control protocols for reusable medical equipment.
Other devices from Oeco
Questions
AI-generated answers, 1 Oct 2026
What is the Oeco Apnea Monitor used for?
The Oeco Apnea Monitor is designed to continuously assess and display a patient’s respiratory rate in real-time. It helps clinicians identify and respond to respiratory abnormalities such as apnea (pauses in breathing) or tachypnea (rapid breathing), making it particularly useful in anesthesia and perioperative care settings where respiratory monitoring is critical.
Is the Oeco Apnea Monitor reusable or single-use?
The Oeco Apnea Monitor is a reusable Class II medical device. As a reusable instrument, it must be cleaned, disinfected, and maintained according to standard infection control protocols for reusable medical equipment to ensure patient safety and device longevity.
What regulatory pathway was followed for the Oeco Apnea Monitor?
The Oeco Apnea Monitor was cleared via a 510(k) Premarket Notification (K811628) under the FDA’s Traditional clearance type. It is classified under the Anesthesiology specialty and regulated under 21 CFR 868.2375, with the FDA Product Code BZQ. The device was determined to be substantially equivalent to a predicate device.
Does the Oeco Apnea Monitor require sterilization?
The regulatory data for the Oeco Apnea Monitor does not specify sterility requirements or MRI safety information. Since it is a reusable device, it must be processed following standard infection control protocols for reusable medical instruments, which typically include cleaning and disinfection rather than sterilization unless indicated by manufacturer guidelines.
What clinical environments is the Oeco Apnea Monitor intended for?
The Oeco Apnea Monitor is intended for use in controlled clinical environments where respiratory monitoring is essential. This includes anesthesia suites, operating rooms, and perioperative care areas where clinicians need to continuously monitor patients’ breathing patterns to detect and address abnormalities like apnea or tachypnea.