The following data is part of a premarket notification filed by Seca Gmbh & Co. Kg with the FDA for Seca Medical Vital Signs Analyzer 535, Seca Mvsa 535, Seca Mvsa, Seca 535.
| Device ID | K192092 |
| 510k Number | K192092 |
| Device Name: | Seca Medical Vital Signs Analyzer 535, Seca MVSA 535, Seca MVSA, Seca 535 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Seca GmbH & Co. Kg Hammer Steindamm 3-25 Hamburg, DE 22089 |
| Contact | Corinna Hatje |
| Correspondent | Oliver Eikenberg Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
| Product Code | DXN |
| Subsequent Product Code | DQA |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-05 |
| Decision Date | 2020-01-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04012030019545 | K192092 | 000 |
| 04012030017862 | K192092 | 000 |
| 04012030017879 | K192092 | 000 |
| 04012030017886 | K192092 | 000 |
| 04012030017923 | K192092 | 000 |
| 04012030017930 | K192092 | 000 |
| 04012030019095 | K192092 | 000 |
| 04012030019118 | K192092 | 000 |
| 04012030019125 | K192092 | 000 |
| 04012030019538 | K192092 | 000 |
| 04012030017855 | K192092 | 000 |