The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Series D Flowmeter.
Device ID | K872718 |
510k Number | K872718 |
Device Name: | SERIES D FLOWMETER |
Classification | Flowmeter, Tube, Thorpe, Back-pressure Compensated |
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 | CAX |
CFR Regulation Number | 868.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-10 |
Decision Date | 1987-08-05 |