The following data is part of a premarket notification filed by Timeter Instrument Corp. with the FDA for M015 Oxygen & Ma15 Air.
Device ID | K791900 |
510k Number | K791900 |
Device Name: | M015 OXYGEN & MA15 AIR |
Classification | Flowmeter, Tube, Thorpe, Back-pressure Compensated |
Applicant | TIMETER INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAX |
CFR Regulation Number | 868.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-09-25 |
Decision Date | 1979-10-11 |