Proneb Turbo Compressor Model 38V0200
510(k) K962072
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK962072 | Date21 Aug 1996 | 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- Withdrawn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
- CAF
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5630
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The Proneb Turbo Compressor Model 38V0200 is a medical device compressor used for respiratory therapy applications. It is designed to power nebulizers that deliver medication to patients through inhalation.
This device is supplied by Pari Holding Co. and is a reusable compressor. It received FDA 510(k) clearance with number K962072 on August 21, 1996, and is classified under product code CAF. The device is intended for use in respiratory therapy settings.
Other devices from Pari Holding Co.
Questions
AI-generated answers, 27 Sep 2026
What is the Proneb Turbo Compressor Model 38V0200 used for?
The Proneb Turbo Compressor Model 38V0200 is a medical device compressor designed specifically for respiratory therapy applications. It powers nebulizers that deliver medication to patients through inhalation, making it essential for respiratory treatments.
Is the Proneb Turbo Compressor reusable or single-use?
The Proneb Turbo Compressor Model 38V0200 is a reusable device designed for multiple uses in respiratory therapy settings. It is not intended for single-use disposal after each treatment.
What regulatory approvals does the Proneb Turbo Compressor have?
The Proneb Turbo Compressor Model 38V0200 received FDA 510(k) clearance with number K962072 on August 21, 1996. It is classified under product code CAF and was determined to be substantially equivalent to predicate devices.
How is the Proneb Turbo Compressor supplied?
The Proneb Turbo Compressor Model 38V0200 is supplied by Pari Holding Co. and is designed for use in respiratory therapy settings. The manufacturer provides the device as a reusable compressor for powering nebulizers in medical environments.