The following data is part of a premarket notification filed by Portex, Inc. with the FDA for 1st Response Intermediate Manual Resuscitator.
| Device ID | K023793 |
| 510k Number | K023793 |
| Device Name: | 1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | PORTEX, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Contact | Cindy Engelhardt |
| Correspondent | Cindy Engelhardt 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 | 2002-11-13 |
| Decision Date | 2003-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30351688431367 | K023793 | 000 |
| 30351688431350 | K023793 | 000 |
| 30351688431336 | K023793 | 000 |
| 30351688431329 | K023793 | 000 |
| 30351688431312 | K023793 | 000 |