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 |