The following data is part of a premarket notification filed by Union Carbide Corp. with the FDA for Linde Oxygen Therapy Flowmeters, L33-l34.
Device ID | K791069 |
510k Number | K791069 |
Device Name: | LINDE OXYGEN THERAPY FLOWMETERS, L33-L34 |
Classification | Flowmeter, Tube, Thorpe, Back-pressure Compensated |
Applicant | UNION CARBIDE 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 | 1979-06-12 |
Decision Date | 1979-06-27 |