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FDA 510(k)

FLOW MED 160

K-Number: K801004 · 1980-05-02

ApplicantD.R.O. Medical, Inc.
Decision Date1980-05-02
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FLOW MED 160 is the device name listed in this FDA 510(k) record. The listed applicant is D.R.O. Medical, Inc.. It received FDA 510(k) clearance on 1980-05-02 under 510(k) number K801004. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLOW MED 160?

FLOW MED 160 is a medical device that received FDA 510(k) clearance on 1980-05-02. The listed applicant is D.R.O. Medical, Inc.. The 510(k) number is K801004.

When did FLOW MED 160 receive FDA 510(k) clearance?

FLOW MED 160 received FDA 510(k) clearance on 1980-05-02, under 510(k) number K801004.

Who is the listed applicant for FLOW MED 160?

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

What is the FDA product code for FLOW MED 160?

The FDA product code for FLOW MED 160 is FPA.

Other records listing D.R.O. Medical, 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.

K844820FLOW MED SK 140 BURETK820165FLOW MED 311K801821FLOW MED 150K801179FLOW MED 160

Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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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