The following data is part of a premarket notification filed by Timeter Instrument Corp. with the FDA for Rt-200 Calibration Analyzer.
Device ID | K822746 |
510k Number | K822746 |
Device Name: | RT-200 CALIBRATION ANALYZER |
Classification | Calibrator, Pressure, Gas |
Applicant | TIMETER INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BXX |
CFR Regulation Number | 868.2620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-09-10 |
Decision Date | 1982-10-13 |