510(k) K801866

PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A by Pentax Precision Instrument Corp. — Product Code EQL

K801866 is an FDA 510(k) premarket notification submitted by Pentax Precision Instrument Corp. for the device "PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A". The FDA issued a decision of Substantially Equivalent on September 16, 1980. The device falls under product code EQL (Laryngostroboscope), a Class I device regulated under 21 CFR 874.4750. Pentax Precision Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1980
Date Received
August 5, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laryngostroboscope
Device Class
Class I
Regulation Number
874.4750
Review Panel
EN
Submission Type