The following data is part of a premarket notification filed by Dynarad Corp. with the FDA for 9150a, 1100f.
Device ID | K932355 |
510k Number | K932355 |
Device Name: | 9150A, 1100F |
Classification | System, X-ray, Mobile |
Applicant | DYNARAD CORP. 19 JEFRYN BLVD. WEST Deer Park, NY 11729 |
Contact | Raymond Manez |
Correspondent | Raymond Manez DYNARAD CORP. 19 JEFRYN BLVD. WEST Deer Park, NY 11729 |
Product Code | IZL |
CFR Regulation Number | 892.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-13 |
Decision Date | 1993-08-03 |