The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Companion 50 Regulator/flowmeter.
Device ID | K872443 |
510k Number | K872443 |
Device Name: | COMPANION 50 REGULATOR/FLOWMETER |
Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
Applicant | PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
Contact | Hartley C Ericson |
Correspondent | Hartley C Ericson PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
Product Code | DRT |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-23 |
Decision Date | 1987-07-21 |