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FDA 510(k)

MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE

K-Number: K012485 · 2001-10-09

ApplicantKing Systems Corp.
Decision Date2001-10-09
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE is the device name listed in this FDA 510(k) record. The listed applicant is King Systems Corp.. It received FDA 510(k) clearance on 2001-10-09 under 510(k) number K012485. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE?

MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE is a medical device that received FDA 510(k) clearance on 2001-10-09. The listed applicant is King Systems Corp.. The 510(k) number is K012485.

When did MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE receive FDA 510(k) clearance?

MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE received FDA 510(k) clearance on 2001-10-09, under 510(k) number K012485.

Who is the listed applicant for MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE?

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

What is the FDA product code for MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE?

The FDA product code for MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE is CAH.

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Other records listing King Systems Corp. as applicant

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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Related Devices (Code: CAH)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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