The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Annular Array Probes For Artis 3200 Diag. Ultra..
| Device ID | K881185 |
| 510k Number | K881185 |
| Device Name: | ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA. |
| Classification | Imager, Ultrasonic Obstetric-gynecologic |
| Applicant | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 5500 AVION PARK DR. Highland Heights, OH 44143 |
| Contact | William J Gerber |
| Correspondent | William J Gerber PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 5500 AVION PARK DR. Highland Heights, OH 44143 |
| Product Code | HEM |
| CFR Regulation Number | 884.2225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-21 |
| Decision Date | 1988-06-01 |