The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Philips Bv Pulsera/endura.
| Device ID | K010435 |
| 510k Number | K010435 |
| Device Name: | PHILIPS BV PULSERA/ENDURA |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. VEENPLUIS 4-6 P.O. BOX 10.000 Da Best, NL 5680 |
| Contact | Marcia Jones |
| Correspondent | Marcia Jones PHILIPS MEDICAL SYSTEMS, INC. VEENPLUIS 4-6 P.O. BOX 10.000 Da Best, NL 5680 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-13 |
| Decision Date | 2001-03-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838055506 | K010435 | 000 |
| 00884838055490 | K010435 | 000 |