The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies, Inc. with the FDA for Mural Perinatal Surveillance.
| Device ID | K220732 |
| 510k Number | K220732 |
| Device Name: | Mural Perinatal Surveillance |
| Classification | System, Monitoring, Perinatal |
| Applicant | GE Medical Systems Information Technologies, Inc. 9900 Innovation Drive Wauwatosa, WI 53226 |
| Contact | Brandon O'Shea |
| Correspondent | Brandon O'Shea GE Medical Systems Information Technologies, Inc. 9900 Innovation Drive Wauwatosa, WI 53226 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-14 |
| Decision Date | 2022-06-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195278726391 | K220732 | 000 |