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FDA 510(k)

AIR FLOW I

K-Number: K823133 · 1982-11-17

ApplicantHealthco, Inc.
Decision Date1982-11-17
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AIR FLOW I is the device name listed in this FDA 510(k) record. The listed applicant is Healthco, Inc.. It received FDA 510(k) clearance on 1982-11-17 under 510(k) number K823133. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIR FLOW I?

AIR FLOW I is a medical device that received FDA 510(k) clearance on 1982-11-17. The listed applicant is Healthco, Inc.. The 510(k) number is K823133.

When did AIR FLOW I receive FDA 510(k) clearance?

AIR FLOW I received FDA 510(k) clearance on 1982-11-17, under 510(k) number K823133.

Who is the listed applicant for AIR FLOW I?

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

What is the FDA product code for AIR FLOW I?

The FDA product code for AIR FLOW I is EIA.

Other records listing Healthco, Inc. 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.

K840984INTERDENTAL WEDGESK823134AIR FLOW IIK821810PIEZON ULTRASONIC SCALER

Related Devices (Code: EIA)

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.

K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)Lakong Medical Devices Co., Ltd.K251626Midmark Dental Delivery SystemMidmark CorporationK251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair BusinessK243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd.,K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd.K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, LLC

Official Source

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

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