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FDA 510(k)

AMEDA HAND BREAST PUMP

K-Number: K823591 · 1982-12-28

ApplicantBurditt & Calkins-Siemens-Elema
Decision Date1982-12-28
Product CodeHGY
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AMEDA HAND BREAST PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Burditt & Calkins-Siemens-Elema. It received FDA 510(k) clearance on 1982-12-28 under 510(k) number K823591. The device is classified under product code HGY. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMEDA HAND BREAST PUMP?

AMEDA HAND BREAST PUMP is a medical device that received FDA 510(k) clearance on 1982-12-28. The listed applicant is Burditt & Calkins-Siemens-Elema. The 510(k) number is K823591.

When did AMEDA HAND BREAST PUMP receive FDA 510(k) clearance?

AMEDA HAND BREAST PUMP received FDA 510(k) clearance on 1982-12-28, under 510(k) number K823591.

Who is the listed applicant for AMEDA HAND BREAST PUMP?

The FDA 510(k) record lists Burditt & Calkins-Siemens-Elema as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMEDA HAND BREAST PUMP?

The FDA product code for AMEDA HAND BREAST PUMP is HGY.

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Other records listing Burditt & Calkins-Siemens-Elema 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.

K833519PULSE GENERATOR MODEL 688K833155RAYDEN MEDICAL MINI PULSE VOLUME RECORDK830344SIEMENS-ELMA PULSE GENERATOR #718K823435MON-A-THERM MYOCARDIAL TEMP. SENSORK822239COAXIAL BIPOLAR PACING ELECTRODEK821712INFORMED REMOTE FIELD UNIT MODEL IFM1000

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Related Devices (Code: HGY)

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.

K101538HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP)Philips Electronics UK LimitedK032845EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187The First Years, Inc.K013226EVENFLO COMFORT EASE MANUAL BREAST PUMP KITEvenflo Company, Inc.K011519AMEDA HYGIENIKITHollister, Inc.K971231WHITE RIVER MINI MANUAL BREAST PUMPWhite River ConceptsK962828EVERT-ITGenesis Industries, 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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