The following data is part of a premarket notification filed by Hudson Respiratory Care, Inc. with the FDA for Hudson Rci Lifesaver Single Patient Use Manual Resuscitator Catalog Numbers: 5360 Through 5380.
| Device ID | K944301 |
| 510k Number | K944301 |
| Device Name: | HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR CATALOG NUMBERS: 5360 THROUGH 5380 |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | HUDSON RESPIRATORY CARE, INC. 27711 DIAZ RD. P.O. BOX 9020 Temecula, CA 92589 -9020 |
| Contact | Arden P Morley |
| Correspondent | Arden P Morley HUDSON RESPIRATORY CARE, INC. 27711 DIAZ RD. P.O. BOX 9020 Temecula, CA 92589 -9020 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-06 |
| Decision Date | 1994-12-21 |