510(k) K881185
K881185 is an FDA 510(k) premarket notification submitted by Philips Medical Systems (Cleveland), Inc. for the device "ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA.". The FDA issued a decision of Substantially Equivalent on June 1, 1988. The device falls under product code HEM (Imager, Ultrasonic Obstetric-Gynecologic), a Class II device regulated under 21 CFR 884.2225. Philips Medical Systems (Cleveland), Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 1, 1988
- Date Received
- March 21, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Imager, Ultrasonic Obstetric-Gynecologic
- Device Class
- Class II
- Regulation Number
- 884.2225
- Review Panel
- OB
- Submission Type