The following data is part of a premarket notification filed by Interspec, Inc. with the FDA for Interspec Apogee, Modification.
Device ID | K910049 |
510k Number | K910049 |
Device Name: | INTERSPEC APOGEE, MODIFICATION |
Classification | Flowmeter, Blood, Cardiovascular |
Applicant | INTERSPEC, INC. 110 WEST BUTLER AVE. Ambler, PA 19002 |
Contact | Arthur J Schenck |
Correspondent | Arthur J Schenck INTERSPEC, INC. 110 WEST BUTLER AVE. Ambler, PA 19002 |
Product Code | DPW |
CFR Regulation Number | 870.2100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-01-07 |
Decision Date | 1991-04-29 |