The following data is part of a premarket notification filed by Air-shields, Inc. with the FDA for Datalogger Chart Recorder.
Device ID | K880781 |
510k Number | K880781 |
Device Name: | DATALOGGER CHART RECORDER |
Classification | Recorder, Paper Chart |
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 | DSF |
CFR Regulation Number | 870.2810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-02-26 |
Decision Date | 1988-05-11 |