The following data is part of a premarket notification filed by Viasys Healthcare Gmbh with the FDA for Masterscreen Paed - Baby Body.
| Device ID | K081823 |
| 510k Number | K081823 |
| Device Name: | MASTERSCREEN PAED - BABY BODY |
| Classification | Plethysmograph, Pressure |
| Applicant | VIASYS HEALTHCARE GMBH LEIBNIZSTRASSE 7 Hoechberg, DE 97204 |
| Contact | Thomas Rust |
| Correspondent | Thomas Rust VIASYS HEALTHCARE GMBH LEIBNIZSTRASSE 7 Hoechberg, DE 97204 |
| Product Code | CCM |
| CFR Regulation Number | 868.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-27 |
| Decision Date | 2009-05-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250892905020 | K081823 | 000 |
| 14250892902521 | K081823 | 000 |
| 14250892902507 | K081823 | 000 |
| 14250892902460 | K081823 | 000 |
| 14250892902262 | K081823 | 000 |
| 14250892903696 | K081823 | 000 |
| 14250892906178 | K081823 | 000 |
| 14250892906161 | K081823 | 000 |
| 14250892906239 | K081823 | 000 |
| 14250892906192 | K081823 | 000 |
| 14250892902538 | K081823 | 000 |
| 14250892902545 | K081823 | 000 |
| 14250892903337 | K081823 | 000 |
| 04250892905013 | K081823 | 000 |
| 04250892905006 | K081823 | 000 |
| 04250892904993 | K081823 | 000 |
| 04250892902708 | K081823 | 000 |
| 04250892902692 | K081823 | 000 |
| 14250892904518 | K081823 | 000 |
| 14250892904259 | K081823 | 000 |
| 14250892903351 | K081823 | 000 |
| 14250892903344 | K081823 | 000 |
| 14250892906185 | K081823 | 000 |