The following data is part of a premarket notification filed by Afp Imaging Corp. with the FDA for Autolaser Multi Format Camera.
Device ID | K950288 |
510k Number | K950288 |
Device Name: | AUTOLASER MULTI FORMAT CAMERA |
Classification | Camera, Multi Format, Radiological |
Applicant | AFP IMAGING CORP. 250 CLEARBROOK RD. Elmsford, NY 10523 |
Contact | David Vozick |
Correspondent | David Vozick AFP IMAGING CORP. 250 CLEARBROOK RD. Elmsford, NY 10523 |
Product Code | LMC |
CFR Regulation Number | 892.2040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-01-25 |
Decision Date | 1995-04-04 |