The following data is part of a premarket notification filed by Obs Medical with the FDA for Biosign Central Station.
| Device ID | K071606 |
| 510k Number | K071606 |
| Device Name: | BIOSIGN CENTRAL STATION |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | OBS MEDICAL 12900 N. MERIDIAN ST. STE. 120 Carmel, IN 46032 |
| Contact | Wayne Nethercutt |
| Correspondent | Wayne Nethercutt OBS MEDICAL 12900 N. MERIDIAN ST. STE. 120 Carmel, IN 46032 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-12 |
| Decision Date | 2007-08-31 |
| Summary: | summary |