The following data is part of a premarket notification filed by Hospitak, Inc. with the FDA for Disposable, Manual Pulmonary Resuscitator.
| Device ID | K873286 |
| 510k Number | K873286 |
| Device Name: | DISPOSABLE, MANUAL PULMONARY RESUSCITATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | HOSPITAK, INC. 1144 ROUTE 109 Lindenhurst, NY 11757 |
| Contact | William J Lacey |
| Correspondent | William J Lacey HOSPITAK, INC. 1144 ROUTE 109 Lindenhurst, NY 11757 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-17 |
| Decision Date | 1987-10-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00084424900574 | K873286 | 000 |
| 00084424900603 | K873286 | 000 |
| 00084424900429 | K873286 | 000 |
| 00084424900337 | K873286 | 000 |
| 00084424900061 | K873286 | 000 |
| 00084424900604 | K873286 | 000 |
| 00084424900573 | K873286 | 000 |
| 00084424900334 | K873286 | 000 |