The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Puritan-bennett Compan Emt W/remote Liq Lev Guage.
Device ID | K903140 |
510k Number | K903140 |
Device Name: | PURITAN-BENNETT COMPAN EMT W/REMOTE LIQ LEV GUAGE |
Classification | Unit, Liquid-oxygen, Portable |
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 | BYJ |
CFR Regulation Number | 868.5655 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-17 |
Decision Date | 1990-09-05 |