The following data is part of a premarket notification filed by Interspec, Inc. with the FDA for Cardioscan With Doppler Option.
Device ID | K862913 |
510k Number | K862913 |
Device Name: | CARDIOSCAN WITH DOPPLER OPTION |
Classification | Transducer, Ultrasonic |
Applicant | INTERSPEC, INC. 1100 E. HECTOR ST. Conshohocken, PA 19428 |
Contact | Schafer, M.sc. |
Correspondent | Schafer, M.sc. INTERSPEC, INC. 1100 E. HECTOR ST. Conshohocken, PA 19428 |
Product Code | JOP |
CFR Regulation Number | 870.2880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-08-01 |
Decision Date | 1986-11-04 |