The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for Type 9293 Interface Pulseox.
Device ID | K896738 |
510k Number | K896738 |
Device Name: | TYPE 9293 INTERFACE PULSEOX |
Classification | Oximeter |
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 | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-30 |
Decision Date | 1990-08-14 |