The following data is part of a premarket notification filed by Allied Healthcare Products, Inc. with the FDA for Resuscitation Timer, Model L770-cpr.
| Device ID | K062080 |
| 510k Number | K062080 |
| Device Name: | RESUSCITATION TIMER, MODEL L770-CPR |
| Classification | Ventilator, Emergency, Manual (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 | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-21 |
| Decision Date | 2006-10-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00260720011537 | K062080 | 000 |
| 00026072011539 | K062080 | 000 |