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FDA 510(k)

PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P

K-Number: K083351 · 2009-04-24

ApplicantComdek Industrial Corp.
Decision Date2009-04-24
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P is the device name listed in this FDA 510(k) record. The listed applicant is Comdek Industrial Corp.. It received FDA 510(k) clearance on 2009-04-24 under 510(k) number K083351. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P?

PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P is a medical device that received FDA 510(k) clearance on 2009-04-24. The listed applicant is Comdek Industrial Corp.. The 510(k) number is K083351.

When did PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P receive FDA 510(k) clearance?

PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P received FDA 510(k) clearance on 2009-04-24, under 510(k) number K083351.

Who is the listed applicant for PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P?

The FDA 510(k) record lists Comdek Industrial Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P?

The FDA product code for PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P is DQA.

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Related Devices (Code: DQA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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