The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for 7250 Metabolic Monitor.
Device ID | K924978 |
510k Number | K924978 |
Device Name: | 7250 METABOLIC MONITOR |
Classification | Computer, Oxygen-uptake |
Applicant | PURITAN BENNETT CORP. 2200 FARADAY AVE. Carlsbad, CA 92008 |
Contact | Les Heins |
Correspondent | Les Heins PURITAN BENNETT CORP. 2200 FARADAY AVE. Carlsbad, CA 92008 |
Product Code | BZL |
CFR Regulation Number | 868.1730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-01 |
Decision Date | 1994-09-22 |