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FDA 510(k)

ELMED LBC 50-P

K-Number: K926517 · 1994-11-15

ApplicantElmed, Inc.
Decision Date1994-11-15
Product CodeHIN
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ELMED LBC 50-P is the device name listed in this FDA 510(k) record. The listed applicant is Elmed, Inc.. It received FDA 510(k) clearance on 1994-11-15 under 510(k) number K926517. The device is classified under product code HIN. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELMED LBC 50-P?

ELMED LBC 50-P is a medical device that received FDA 510(k) clearance on 1994-11-15. The listed applicant is Elmed, Inc.. The 510(k) number is K926517.

When did ELMED LBC 50-P receive FDA 510(k) clearance?

ELMED LBC 50-P received FDA 510(k) clearance on 1994-11-15, under 510(k) number K926517.

Who is the listed applicant for ELMED LBC 50-P?

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 ELMED LBC 50-P?

The FDA product code for ELMED LBC 50-P is HIN.

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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.

K010465DENSTATK974793ELMED ESU 120 M/M DIGITALK953271ELMED RF-ALERTK952110ELMED THERMO-FLUXK932938ELMED ESU 300 M/M AND DIGITALK921770ELECTROSURGICAL UNITS ESU 100L, 100 L M/M & E M/M

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Related Devices (Code: HIN)

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.

K130305LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZELina Medical ApsK122983KSEA BIPOLAR ELECTRODEKARL STORZ Endoscopy-America, Inc.K122605PKS BILLGyrus Acmi, Inc.K113080TUBALGATORMectra Labs, Inc.K111751VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERSETHICON, Inc.K111059GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)Gyrus Acmi, Inc.

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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