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FDA 510(k)

BKMI DISPOSABLE SYRINGE

K-Number: K971487 · 1997-09-04

ApplicantSumi Salud C.A.
Decision Date1997-09-04
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BKMI DISPOSABLE SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Sumi Salud C.A.. It received FDA 510(k) clearance on 1997-09-04 under 510(k) number K971487. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BKMI DISPOSABLE SYRINGE?

BKMI DISPOSABLE SYRINGE is a medical device that received FDA 510(k) clearance on 1997-09-04. The listed applicant is Sumi Salud C.A.. The 510(k) number is K971487.

When did BKMI DISPOSABLE SYRINGE receive FDA 510(k) clearance?

BKMI DISPOSABLE SYRINGE received FDA 510(k) clearance on 1997-09-04, under 510(k) number K971487.

Who is the listed applicant for BKMI DISPOSABLE SYRINGE?

The FDA 510(k) record lists Sumi Salud C.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BKMI DISPOSABLE SYRINGE?

The FDA product code for BKMI DISPOSABLE SYRINGE is FMI.

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Related Devices (Code: FMI)

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

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