Aerochamber
510(k) K872037
Aerochamber is a medical device (FDA Class I; FDA product code BYP, Mouthpiece, Breathing) made by Monaghan Medical Corp., cleared under FDA 510(k) K872037 on 24 Jul 1987, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK872037 | Date24 Jul 1987 | StatusActive |
Official records
- FDA 510(k) database K872037
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- BYP
- Device class
- Class I
- Regulation
- 21 CFR Part 868.5620
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
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- MEDIPART DISPOS. MOUTHPIECE W/22MM O.D. MP-4411 by Medipart Jerry Alexander