The following data is part of a premarket notification filed by Fisher Imaging Corp. with the FDA for Bpa Cardiovascular Pressure Amplifier.
Device ID | K870783 |
510k Number | K870783 |
Device Name: | BPA CARDIOVASCULAR PRESSURE AMPLIFIER |
Classification | Amplifier And Signal Conditioner, Transducer Signal |
Applicant | FISHER IMAGING CORP. 125 SOUTH FIFTH ST. P.O. BOX 0342 Reading, PA 19603 |
Contact | Murray Bloom |
Correspondent | Murray Bloom FISHER IMAGING CORP. 125 SOUTH FIFTH ST. P.O. BOX 0342 Reading, PA 19603 |
Product Code | DRQ |
CFR Regulation Number | 870.2060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-26 |
Decision Date | 1987-04-27 |