The following data is part of a premarket notification filed by Cerner Corp. with the FDA for Cerner Fetalink+(version1.0).
| Device ID | K121758 |
| 510k Number | K121758 |
| Device Name: | CERNER FETALINK+(VERSION1.0) |
| Classification | System, Monitoring, Perinatal |
| Applicant | CERNER CORP. 10234 MARION PARK DRIVE Kansas City, MO 64137 |
| Contact | Shelley S Looby |
| Correspondent | Shelley S Looby CERNER CORP. 10234 MARION PARK DRIVE Kansas City, MO 64137 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-15 |
| Decision Date | 2012-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853023006166 | K121758 | 000 |
| 00853023006142 | K121758 | 000 |
| 00853023006050 | K121758 | 000 |
| 00853023006210 | K121758 | 000 |
| 00850017753112 | K121758 | 000 |