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FDA 510(k)

INSULIN PUMP INSUMAT 229

K-Number: K853393 · 1985-11-18

ApplicantMedix Medical Electronics (U.S.A.), Inc.
Decision Date1985-11-18
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INSULIN PUMP INSUMAT 229 is the device name listed in this FDA 510(k) record. The listed applicant is Medix Medical Electronics (U.S.A.), Inc.. It received FDA 510(k) clearance on 1985-11-18 under 510(k) number K853393. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSULIN PUMP INSUMAT 229?

INSULIN PUMP INSUMAT 229 is a medical device that received FDA 510(k) clearance on 1985-11-18. The listed applicant is Medix Medical Electronics (U.S.A.), Inc.. The 510(k) number is K853393.

When did INSULIN PUMP INSUMAT 229 receive FDA 510(k) clearance?

INSULIN PUMP INSUMAT 229 received FDA 510(k) clearance on 1985-11-18, under 510(k) number K853393.

Who is the listed applicant for INSULIN PUMP INSUMAT 229?

The FDA 510(k) record lists Medix Medical Electronics (U.S.A.), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INSULIN PUMP INSUMAT 229?

The FDA product code for INSULIN PUMP INSUMAT 229 is FRN.

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Other records listing Medix Medical Electronics (U.S.A.), Inc. as applicant

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Related Devices (Code: FRN)

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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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