510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863818Substantially Equivalent

Pm-100 Thermograph Mark 1026

Clearwater Computer Center, Inc., Clearwater FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863818 is the FDA 510(k) clearance record for PM-100 THERMOGRAPH MARK 1026, a class I device, cleared for Clearwater Computer Center, Inc. on under FDA product code LHQ (System, Telethermographic (Adjunctive Use)). FDA records list one 510(k) clearance for Clearwater Computer Center, Inc. As of , FDA records show no recalls naming K863818.

Clearance record

Decision date
Received
(185 days to decision)
Product code
LHQ System, Telethermographic (Adjunctive Use)
Regulation
21 CFR 884.2980
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Clearwater Computer Center, Inc. 3447 Us. Hwy. 19 N., Clearwater FL
Third party review
No

Clearances, product code LHQ

Trailing 12 months
1 clearance under product code LHQ in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LHQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260