The following data is part of a premarket notification filed by Allied Healthcare Products, Inc. with the FDA for Mass Casualty Ventilators, Models: Mcv200 And Mcv200-b.
| Device ID | K083385 |
| 510k Number | K083385 |
| Device Name: | MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B |
| 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 | 2008-11-17 |
| Decision Date | 2009-05-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00260720001590 | K083385 | 000 |
| 00026072001530 | K083385 | 000 |
| 00026072001547 | K083385 | 000 |
| 00026072001554 | K083385 | 000 |
| 00026072001561 | K083385 | 000 |
| 00026072001578 | K083385 | 000 |
| 00026072001585 | K083385 | 000 |
| 00026072001592 | K083385 | 000 |
| 00260720001521 | K083385 | 000 |
| 00260720001538 | K083385 | 000 |
| 00260720001545 | K083385 | 000 |
| 00260720001552 | K083385 | 000 |
| 00260720001569 | K083385 | 000 |
| 00260720001576 | K083385 | 000 |
| 00260720001583 | K083385 | 000 |
| 00026072001523 | K083385 | 000 |