The following data is part of a premarket notification filed by Lifeguard Medical Products, Inc. with the FDA for Lifeguard Single Use Manual Resuscitators.
| Device ID | K881087 |
| 510k Number | K881087 |
| Device Name: | LIFEGUARD SINGLE USE MANUAL RESUSCITATORS |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | LIFEGUARD MEDICAL PRODUCTS, INC. 7476 SHADELAND STATION WAY Indianapolis, IN 46256 |
| Contact | Craig Trimble |
| Correspondent | Craig Trimble LIFEGUARD MEDICAL PRODUCTS, INC. 7476 SHADELAND STATION WAY Indianapolis, IN 46256 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-14 |
| Decision Date | 1988-04-14 |