510(k) K013308
- Device
- VENTLAB HYPERINFLATION BAG SYSTEM
- Applicant
- Ventlab Corp.
- 510(k) number
- K013308
- Product code
- NHK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-12-20
- Date received
- 2001-10-04
- Regulation
- 868.5905
- Classification name
- Resuscitator, Manual, Non Self-Inflating
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- MARGE WALLS-WALKER
- Address
- 2934 Hwy. 601 N. Mocksville NC US 27028 27028
FDA Registration Numbers#
- 8043316
- 3006783791
- 3005998497
- 3012307300
- 8044169
- 9617604
- 1024404
- 1314417
- 2032112
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NHK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K092687 | VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER | A Plus Medical | 2009-11-23 |
| K020281 | MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM | Ventlab Corp. | 2002-02-11 |
| K001714 | MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149 | Mercury Medical | 2000-11-03 |
| K970785 | SIMS HYPERINFLATION BAG SYSTEM | Sims | 1997-06-13 |
| K952214 | SIMS INTERTECH HYPERINFLATION BAG SYSTEM | Intertech Resources, Inc. | 1995-06-08 |
| K942571 | HYPER-INFLATION BAG | Med-Plastics Intl., Inc. | 1994-06-10 |
| K940255 | HYPERINFLATION BAG SYSTEM | Nutec, Inc. | 1994-02-17 |
| K894612 | INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM | Intertech Resources, Inc. | 1989-09-08 |
| K813317 | DISP. HYPERINFLATION BAG SYSTEM | Intec Medical, Inc. | 1982-03-12 |