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FDA 510(k)

DENSTAT

K-Number: K010465 · 2001-05-14

ApplicantElmed, Inc.
Decision Date2001-05-14
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DENSTAT is the device name listed in this FDA 510(k) record. The listed applicant is Elmed, Inc.. It received FDA 510(k) clearance on 2001-05-14 under 510(k) number K010465. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENSTAT?

DENSTAT is a medical device that received FDA 510(k) clearance on 2001-05-14. The listed applicant is Elmed, Inc.. The 510(k) number is K010465.

When did DENSTAT receive FDA 510(k) clearance?

DENSTAT received FDA 510(k) clearance on 2001-05-14, under 510(k) number K010465.

Who is the listed applicant for DENSTAT?

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

What is the FDA product code for DENSTAT?

The FDA product code for DENSTAT is GEI.

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Other records listing Elmed, 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.

K974793ELMED ESU 120 M/M DIGITALK953271ELMED RF-ALERTK952110ELMED THERMO-FLUXK926517ELMED LBC 50-PK932938ELMED ESU 300 M/M AND DIGITALK921770ELECTROSURGICAL UNITS ESU 100L, 100 L M/M & E M/M

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Related Devices (Code: GEI)

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

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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