The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for M2540 Diagnostic Ultrasound System, Model M2540.
| Device ID | K014191 |
| 510k Number | K014191 |
| Device Name: | M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Contact | Steve Singlar |
| Correspondent | Mark Job TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-12-21 |
| Decision Date | 2002-01-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838068117 | K014191 | 000 |
| 00884838067660 | K014191 | 000 |
| 00884838067592 | K014191 | 000 |
| 00884838067585 | K014191 | 000 |
| 00884838067486 | K014191 | 000 |
| 00884838065352 | K014191 | 000 |
| 00884838061750 | K014191 | 000 |
| 00884838061736 | K014191 | 000 |
| 00884838061705 | K014191 | 000 |
| 00884838067721 | K014191 | 000 |
| 00884838067745 | K014191 | 000 |
| 00884838068100 | K014191 | 000 |
| 00884838068087 | K014191 | 000 |
| 00884838068056 | K014191 | 000 |
| 00884838068049 | K014191 | 000 |
| 00884838068032 | K014191 | 000 |
| 00884838068025 | K014191 | 000 |
| 00884838068018 | K014191 | 000 |
| 00884838067950 | K014191 | 000 |
| 00884838061378 | K014191 | 000 |