The following data is part of a premarket notification filed by Plasco, Inc. with the FDA for Cpr Filtershield.
| Device ID | K980066 |
| 510k Number | K980066 |
| Device Name: | CPR FILTERSHIELD |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | PLASCO, INC. 4080 MORRISON DR. Gurnee, IL 60031 |
| Contact | Gary S Botsford |
| Correspondent | Gary S Botsford PLASCO, INC. 4080 MORRISON DR. Gurnee, IL 60031 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-07 |
| Decision Date | 1998-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50748426074247 | K980066 | 000 |