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.
| Device ID | K964719 |
| 510k Number | K964719 |
| Device Name: | HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR |
| 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 | 1996-11-25 |
| Decision Date | 1997-02-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 34026704596554 | K964719 | 000 |
| 34026704662624 | K964719 | 000 |
| 34026704662617 | K964719 | 000 |
| 24026704587845 | K964719 | 000 |
| 24026704587616 | K964719 | 000 |
| 24026704587609 | K964719 | 000 |
| 24026704587593 | K964719 | 000 |
| 24026704551136 | K964719 | 000 |
| 24026704551129 | K964719 | 000 |
| 24026704551105 | K964719 | 000 |
| 24026704551099 | K964719 | 000 |
| 24026704734164 | K964719 | 000 |
| 34026704662631 | K964719 | 000 |
| 34026704662648 | K964719 | 000 |
| 34026704662655 | K964719 | 000 |
| 34026704387909 | K964719 | 000 |
| 34026704662730 | K964719 | 000 |
| 34026704662723 | K964719 | 000 |
| 34026704662600 | K964719 | 000 |
| 34026704662747 | K964719 | 000 |
| 34026704662716 | K964719 | 000 |
| 34026704662709 | K964719 | 000 |
| 34026704662693 | K964719 | 000 |
| 34026704662686 | K964719 | 000 |
| 34026704662679 | K964719 | 000 |
| 34026704662662 | K964719 | 000 |
| 24026704734157 | K964719 | 000 |