The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for System Athena-product Enhancements, Anesthesia.
Device ID | K912145 |
510k Number | K912145 |
Device Name: | SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA |
Classification | Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling |
Applicant | S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark, DK |
Contact | Lisbeth Isbrandt |
Correspondent | Lisbeth Isbrandt S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark, DK |
Product Code | CCE |
CFR Regulation Number | 868.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-09 |
Decision Date | 1992-05-05 |