The following data is part of a premarket notification filed by Ventlab Corp. with the FDA for V*care Manual Resuscitator, Cat#vr-1000.
| Device ID | K913900 |
| 510k Number | K913900 |
| Device Name: | V*CARE MANUAL RESUSCITATOR, CAT#VR-1000 |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | VENTLAB CORP. BUILDING 14E EASY ST. P.O. BOX 244 Bound Brook, NJ 08805 |
| Contact | Gregory Lau |
| Correspondent | Gregory Lau VENTLAB CORP. BUILDING 14E EASY ST. P.O. BOX 244 Bound Brook, NJ 08805 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-30 |
| Decision Date | 1992-01-07 |