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FDA 510(k)

DIGI-INJECTOR

K-Number: K971067 · 1997-09-19

Decision Date1997-09-19
Product CodeMRH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DIGI-INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Medical Instrument Development Laboratories, Inc.. It received FDA 510(k) clearance on 1997-09-19 under 510(k) number K971067. The device is classified under product code MRH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGI-INJECTOR?

DIGI-INJECTOR is a medical device that received FDA 510(k) clearance on 1997-09-19. The listed applicant is Medical Instrument Development Laboratories, Inc.. The 510(k) number is K971067.

When did DIGI-INJECTOR receive FDA 510(k) clearance?

DIGI-INJECTOR received FDA 510(k) clearance on 1997-09-19, under 510(k) number K971067.

Who is the listed applicant for DIGI-INJECTOR?

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

What is the FDA product code for DIGI-INJECTOR?

The FDA product code for DIGI-INJECTOR is MRH.

Related Clinical Trials

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.

Other records listing Medical Instrument Development Laboratories, 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.

View all 22 devices →

Related Devices (Code: MRH)

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.

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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