The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Philips Avalon Cts Cordless Fetal Transducer System, Models M2720a, M2725a, M2726a, M2727a.
| Device ID | K023931 |
| 510k Number | K023931 |
| Device Name: | PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A |
| Classification | System, Monitoring, Perinatal |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. NEDERLAND B.V. POSTBUS 10.000 Da Best, NL 5680 |
| Contact | Markus Stacha |
| Correspondent | Markus Stacha PHILIPS MEDICAL SYSTEMS, INC. NEDERLAND B.V. POSTBUS 10.000 Da Best, NL 5680 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-26 |
| Decision Date | 2003-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838009431 | K023931 | 000 |
| 00884838009424 | K023931 | 000 |
| 00884838002692 | K023931 | 000 |
| 00884838002685 | K023931 | 000 |
| 00884838002678 | K023931 | 000 |
| 20884838008629 | K023931 | 000 |
| 20884838008346 | K023931 | 000 |
| 20884838003235 | K023931 | 000 |