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FDA 510(k)

AIR SHIELDS AS461 MONITORING SYS

K-Number: K842321 · 1984-08-03

ApplicantAir-Shields, Inc.
Decision Date1984-08-03
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AIR SHIELDS AS461 MONITORING SYS is the device name listed in this FDA 510(k) record. The listed applicant is Air-Shields, Inc.. It received FDA 510(k) clearance on 1984-08-03 under 510(k) number K842321. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIR SHIELDS AS461 MONITORING SYS?

AIR SHIELDS AS461 MONITORING SYS is a medical device that received FDA 510(k) clearance on 1984-08-03. The listed applicant is Air-Shields, Inc.. The 510(k) number is K842321.

When did AIR SHIELDS AS461 MONITORING SYS receive FDA 510(k) clearance?

AIR SHIELDS AS461 MONITORING SYS received FDA 510(k) clearance on 1984-08-03, under 510(k) number K842321.

Who is the listed applicant for AIR SHIELDS AS461 MONITORING SYS?

The FDA 510(k) record lists Air-Shields, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIR SHIELDS AS461 MONITORING SYS?

The FDA product code for AIR SHIELDS AS461 MONITORING SYS is DRT.

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Related Devices (Code: DRT)

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K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.

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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