510(k) K760972
K760972 is an FDA 510(k) premarket notification submitted by Taylor Instrument Analytics Co. for the device "TYCOS DIAGNOSTIC PENLIGHT". The FDA issued a decision of Substantially Equivalent on January 26, 1977. The device falls under product code KYT (Light, Examination, Medical, Battery Powered), a Class I device regulated under 21 CFR 880.6350. Taylor Instrument Analytics Co. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 1977
- Date Received
- November 4, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Examination, Medical, Battery Powered
- Device Class
- Class I
- Regulation Number
- 880.6350
- Review Panel
- HO
- Submission Type