The following data is part of a premarket notification filed by Portex, Inc. with the FDA for 1st Response Manual Resuscitator, Model 85xx.
| Device ID | K014115 |
| 510k Number | K014115 |
| Device Name: | 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | PORTEX, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Contact | Timothy J Talcott |
| Correspondent | Timothy J Talcott PORTEX, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-14 |
| Decision Date | 2002-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019315060940 | K014115 | 000 |
| 35019315060902 | K014115 | 000 |
| 35019315060896 | K014115 | 000 |
| 35019315052501 | K014115 | 000 |
| 35019315049488 | K014115 | 000 |
| 30351688431541 | K014115 | 000 |