510(k) K830715

NORELCO VIBRATING BOARD V900 by North American Philips Corp. — Product Code IRO

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