The following data is part of a premarket notification filed by Life Support Products, Inc. with the FDA for 502 Resuscitatory Inhalator Valve.
| Device ID | K851337 |
| 510k Number | K851337 |
| Device Name: | 502 RESUSCITATORY INHALATOR VALVE |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | LIFE SUPPORT PRODUCTS, INC. 1340 NORTH JEFFERSON P.O. BOX 6146 Anaheim, CA 92806 |
| Contact | Donald C Fabish |
| Correspondent | Donald C Fabish LIFE SUPPORT PRODUCTS, INC. 1340 NORTH JEFFERSON P.O. BOX 6146 Anaheim, CA 92806 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-03 |
| Decision Date | 1985-05-15 |