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 |