The following data is part of a premarket notification filed by Hudson Oxygen Therapy Sales Co. with the FDA for Lifesaver, Manual #5160.
Device ID | K780216 |
510k Number | K780216 |
Device Name: | LIFESAVER, MANUAL #5160 |
Classification | Ventilator, Emergency, Manual (resuscitator) |
Applicant | HUDSON OXYGEN THERAPY SALES CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BTM |
CFR Regulation Number | 868.5915 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-02-10 |
Decision Date | 1978-03-14 |