510(k) K882816
K882816 is an FDA 510(k) premarket notification submitted by Apex Medical, Inc. for the device "PULSAR EM". The FDA issued a decision of Substantially Equivalent on April 27, 1989. The device falls under product code ILX (Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5290. Apex Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 27, 1989
- Date Received
- July 8, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
- Device Class
- Class II
- Regulation Number
- 890.5290
- Review Panel
- PM
- Submission Type