510(k) K813451

UVA FLUORESCENT TANNING LAMPS by North American Philips Corp. — Product Code IOB

K813451 is an FDA 510(k) premarket notification submitted by North American Philips Corp. for the device "UVA FLUORESCENT TANNING LAMPS". The FDA issued a decision of Substantially Equivalent on January 28, 1982. The device falls under product code IOB (Lamp, Infrared, Non Heating), a Class II device regulated under 21 CFR 890.5500. North American Philips Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1982
Date Received
December 10, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Infrared, Non Heating
Device Class
Class II
Regulation Number
890.5500
Review Panel
PM
Submission Type