The following data is part of a premarket notification filed by Timeter Instrument Corp. with the FDA for Aridyne 3500.
Device ID | K790912 |
510k Number | K790912 |
Device Name: | ARIDYNE 3500 |
Classification | Compressor, Air, Portable |
Applicant | TIMETER INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BTI |
CFR Regulation Number | 868.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-05-14 |
Decision Date | 1979-05-21 |