The following data is part of a premarket notification filed by Clinical Computer Systems, Inc. with the FDA for Obix Perinatal Data System 7.0.
| Device ID | K121208 |
| 510k Number | K121208 |
| Device Name: | OBIX PERINATAL DATA SYSTEM 7.0 |
| Classification | System, Monitoring, Perinatal |
| Applicant | CLINICAL COMPUTER SYSTEMS, INC. 715 TOLLGATE RD. UNIT H Elgin, IL 60123 -9331 |
| Contact | Cynthia Bell |
| Correspondent | William Sammons INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-04-20 |
| Decision Date | 2012-06-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868102000423 | K121208 | 000 |
| 00868102000416 | K121208 | 000 |
| 00868102000447 | K121208 | 000 |