The following data is part of a premarket notification filed by Seca Gmbh & Co. Kg with the FDA for Seca Medical Body Compostion Analyzer 514, Seca Mbca 514, Seca Mbca, Seca 514.
| Device ID | K122388 |
| 510k Number | K122388 |
| Device Name: | SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514 |
| Classification | Analyzer, Body Composition |
| Applicant | SECA GMBH & CO. KG 1300 I STREET, NW, 11TH FLOOR EAST Washington, DC 20005 -3314 |
| Contact | Seth A Mailhot |
| Correspondent | Seth A Mailhot SECA GMBH & CO. KG 1300 I STREET, NW, 11TH FLOOR EAST Washington, DC 20005 -3314 |
| Product Code | MNW |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-06 |
| Decision Date | 2013-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04012030013369 | K122388 | 000 |
| 04012030013352 | K122388 | 000 |