The following data is part of a premarket notification filed by Corometrics Medical Systems, Inc. with the FDA for Ssd-620 Linear/convex Array Sector Scanner.
Device ID | K880900 |
510k Number | K880900 |
Device Name: | SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER |
Classification | Imager, Ultrasonic Obstetric-gynecologic |
Applicant | COROMETRICS MEDICAL SYSTEMS, INC. 61 BARNES PARK RD. NORTH P.O. BOX 333 Wallingford, CT 06492 |
Contact | Joseph P Lenzen |
Correspondent | Joseph P Lenzen COROMETRICS MEDICAL SYSTEMS, INC. 61 BARNES PARK RD. NORTH P.O. BOX 333 Wallingford, CT 06492 |
Product Code | HEM |
CFR Regulation Number | 884.2225 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-02 |
Decision Date | 1988-06-01 |