510(k) K830715
K830715 is an FDA 510(k) premarket notification submitted by North American Philips Corp. for the device "NORELCO VIBRATING BOARD V900". The FDA issued a decision of Substantially Equivalent on May 25, 1983. The device falls under product code IRO (Vibrator, Therapeutic), a Class I device regulated under 21 CFR 890.5975. North American Philips Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 25, 1983
- Date Received
- March 9, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vibrator, Therapeutic
- Device Class
- Class I
- Regulation Number
- 890.5975
- Review Panel
- PM
- Submission Type