Ventlab Hyperinflation Bag System
510(k) K013308
Ventlab Hyperinflation Bag System is a medical device (FDA Class II; FDA product code NHK, Resuscitator, Manual, Non Self-Inflating) made by Ventlab Corp., cleared under FDA 510(k) K013308 on 20 Dec 2001, 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 | NumberK013308 | Date20 Dec 2001 | StatusActive |
Official records
- FDA 510(k) database K013308
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NHK
- Device class
- Class II
- Regulation
- 21 CFR Part 868.5905
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code NHK (Resuscitator, Manual, Non Self-Inflating).
- DISP. HYPERINFLATION BAG SYSTEM by Intec Medical, Inc.
- SIMS HYPERINFLATION BAG SYSTEM by Sims
- Hyperinflation Bag System, Model 83-900-0149 by Mercury Medical
- VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER by A Plus Medical
- INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM by Intertech Resources, Inc.
- HYPERINFLATION BAG SYSTEM by Nutec, Inc.
- HYPER-INFLATION BAG by Med-Plastics Intl., Inc.
- Sims Intertech Hyperinflation Bag System by Intertech Resources, Inc.