The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for 9267 Spo2 Athena Module.
Device ID | K940933 |
510k Number | K940933 |
Device Name: | 9267 SPO2 ATHENA MODULE |
Classification | Oximeter |
Applicant | S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark, DK |
Contact | Morten Nielsen |
Correspondent | Morten Nielsen S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark, DK |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-28 |
Decision Date | 1995-11-29 |