The following data is part of a premarket notification filed by Air-shields, Inc. with the FDA for Examination Lamp.
Device ID | K922150 |
510k Number | K922150 |
Device Name: | EXAMINATION LAMP |
Classification | Device, Medical Examination, Ac Powered |
Applicant | AIR-SHIELDS, INC. 330 JACKSONVILLE RD. Hatboro, PA 19040 |
Contact | Francis X Casey |
Correspondent | Francis X Casey AIR-SHIELDS, INC. 330 JACKSONVILLE RD. Hatboro, PA 19040 |
Product Code | KZF |
CFR Regulation Number | 880.6320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-07 |
Decision Date | 1992-07-21 |