The following data is part of a premarket notification filed by Allied Healthcare Products, Inc. with the FDA for Battery Pack For Mcv100 And Mcv200 Emergency Ventilators.
| Device ID | K083507 |
| 510k Number | K083507 |
| Device Name: | BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | ALLIED HEALTHCARE PRODUCTS, INC. 1720 SUBLETTE AVE. St. Louis, MO 63110 |
| Contact | Wayne Karcher |
| Correspondent | Wayne Karcher ALLIED HEALTHCARE PRODUCTS, INC. 1720 SUBLETTE AVE. St. Louis, MO 63110 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-26 |
| Decision Date | 2009-05-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00260720001606 | K083507 | 000 |
| 00026072001608 | K083507 | 000 |