The following data is part of a premarket notification filed by Cerner Corp. with the FDA for Cerner Fetalink (version 1.0).
| Device ID | K091251 |
| 510k Number | K091251 |
| Device Name: | CERNER FETALINK (VERSION 1.0) |
| Classification | System, Monitoring, Perinatal |
| Applicant | CERNER CORP. 2800 ROCKCREEK PKWY. Kansas City, MO 64117 |
| Contact | Shelley S Looby |
| Correspondent | Shelley S Looby CERNER CORP. 2800 ROCKCREEK PKWY. Kansas City, MO 64117 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-29 |
| Decision Date | 2009-08-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853023006081 | K091251 | 000 |
| 00853023006043 | K091251 | 000 |
| 00853023006227 | K091251 | 000 |