The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Modified Single Patient Use Disp Man Resuscitator.
Device ID | K903443 |
510k Number | K903443 |
Device Name: | MODIFIED SINGLE PATIENT USE DISP MAN RESUSCITATOR |
Classification | Ventilator, Emergency, Manual (resuscitator) |
Applicant | PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
Contact | Marshall Smith |
Correspondent | Marshall Smith PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
Product Code | BTM |
CFR Regulation Number | 868.5915 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-31 |
Decision Date | 1990-08-17 |