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FDA 510(k)

PEEPER

K-Number: K830395 · 1983-03-11

ApplicantDupaco, Inc.
Decision Date1983-03-11
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PEEPER is the device name listed in this FDA 510(k) record. The listed applicant is Dupaco, Inc.. It received FDA 510(k) clearance on 1983-03-11 under 510(k) number K830395. The device is classified under product code BYE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEEPER?

PEEPER is a medical device that received FDA 510(k) clearance on 1983-03-11. The listed applicant is Dupaco, Inc.. The 510(k) number is K830395.

When did PEEPER receive FDA 510(k) clearance?

PEEPER received FDA 510(k) clearance on 1983-03-11, under 510(k) number K830395.

Who is the listed applicant for PEEPER?

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

What is the FDA product code for PEEPER?

The FDA product code for PEEPER is BYE.

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.

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Other records listing Dupaco, 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.

K841581UNIFILTER ANESTHESIA & RESPIRATORY FILTK821434EKG (ECG) ELECTRODESK770084OPERATING ROOM VENTILATOR

Related Devices (Code: BYE)

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.

K160112Besmed PEEP ValveBesmed Health Business CorpK122610PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIESSen MU Technology Co., Ltd.K112546O_TWO CPAP SYSTEMO-Two Medical Technologies, Inc.K110713WATERPAP VALVEAirways Development, LLCK103833NEOPIP PATIENT CIRCUIT WITH PEEPNeoforce Group, Inc.K092029VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310Draeger Medical AG & Co. KG

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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