510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K083351Substantially Equivalent

Proable Pulse Oximeter, Model Md-600P, Traveler Oximeter, Model Md-650P and Palm Pulse Oximeter, Model Md-680P

Comdek Industrial Corp., Taipei, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K083351 is the FDA 510(k) clearance record for PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P, a class II device, cleared for Comdek Industrial Corp. on under FDA product code DQA (Oximeter). FDA records list one 510(k) clearance for Comdek Industrial Corp. As of , FDA records show no recalls naming K083351.

Clearance record

Decision date
Received
(162 days to decision)
Product code
DQA Oximeter
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Comdek Industrial Corp. 9f-1, # 3 Yuan Qu St., Taipei, TW
510(k) summary
Statement
Third party review
No

Clearances, product code DQA

Trailing 12 months
13 clearances under product code DQA in the twelve months to October 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQA, trailing twelve months
MonthClearances
November 20252
December 20253
January 20261
February 20262
March 20260
April 20261
May 20263
June 20260
July 20260
August 20260
September 20260
October 20261