The following data is part of a premarket notification filed by A2j, Inc. with the FDA for Az 92.
Device ID | K931974 |
510k Number | K931974 |
Device Name: | AZ 92 |
Classification | Monitor, Patient Position, Light-beam |
Applicant | A2J, INC. 225 INDUSTRIAL CT. Fredericksburg, VA 22408 |
Contact | Jim L. |
Correspondent | Jim L. A2J, INC. 225 INDUSTRIAL CT. Fredericksburg, VA 22408 |
Product Code | IWE |
CFR Regulation Number | 892.5780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-22 |
Decision Date | 1993-10-08 |