The following data is part of a premarket notification filed by Hudson Oxygen Therapy Sales Co. with the FDA for Manual Resuscitator.
| Device ID | K895589 |
| 510k Number | K895589 |
| Device Name: | MANUAL RESUSCITATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | HUDSON OXYGEN THERAPY SALES CO. 27711 DIAZ ST. P.O. BOX 66 Temecula, CA 92390 |
| Contact | Jorge Haider |
| Correspondent | Jorge Haider HUDSON OXYGEN THERAPY SALES CO. 27711 DIAZ ST. P.O. BOX 66 Temecula, CA 92390 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-15 |
| Decision Date | 1990-03-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04710810093234 | K895589 | 000 |
| 34026704662297 | K895589 | 000 |
| 34026704662280 | K895589 | 000 |
| 34026704662341 | K895589 | 000 |
| 34026704662334 | K895589 | 000 |
| 34026704662273 | K895589 | 000 |
| 34026704662266 | K895589 | 000 |
| 34026704662259 | K895589 | 000 |
| 34026704662235 | K895589 | 000 |
| 34026704662204 | K895589 | 000 |
| 34026704662310 | K895589 | 000 |
| 34026704662358 | K895589 | 000 |
| 04710810093227 | K895589 | 000 |
| 04710810093210 | K895589 | 000 |
| 04710810093203 | K895589 | 000 |
| 04710810093197 | K895589 | 000 |
| 24710810093184 | K895589 | 000 |
| 34026704662181 | K895589 | 000 |
| 34026704662402 | K895589 | 000 |
| 34026704662396 | K895589 | 000 |
| 34026704662389 | K895589 | 000 |
| 34026704662174 | K895589 | 000 |