The following data is part of a premarket notification filed by Interspec, Inc. with the FDA for Interspec Apogee Rx400 Ultrasound Imaging System And Doppler Ultrasound Flowmeter.
Device ID | K940671 |
510k Number | K940671 |
Device Name: | INTERSPEC APOGEE RX400 ULTRASOUND IMAGING SYSTEM AND DOPPLER ULTRASOUND FLOWMETER |
Classification | Transducer, Ultrasonic, Diagnostic |
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 | ITX |
CFR Regulation Number | 892.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-16 |
Decision Date | 1994-11-22 |