The following data is part of a premarket notification filed by Siemens Corp. with the FDA for Oxygen Analyzer 110.
Device ID | K780185 |
510k Number | K780185 |
Device Name: | OXYGEN ANALYZER 110 |
Classification | Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling |
Applicant | SIEMENS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CCC |
CFR Regulation Number | 868.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-02-06 |
Decision Date | 1978-03-17 |