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FDA 510(k)

AMPLITONE-3

K-Number: K812676 · 1981-10-13

ApplicantProgressive Technology, Inc.
Decision Date1981-10-13
Product CodeLDE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMPLITONE-3 is the device name listed in this FDA 510(k) record. The listed applicant is Progressive Technology, Inc.. It received FDA 510(k) clearance on 1981-10-13 under 510(k) number K812676. The device is classified under product code LDE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMPLITONE-3?

AMPLITONE-3 is a medical device that received FDA 510(k) clearance on 1981-10-13. The listed applicant is Progressive Technology, Inc.. The 510(k) number is K812676.

When did AMPLITONE-3 receive FDA 510(k) clearance?

AMPLITONE-3 received FDA 510(k) clearance on 1981-10-13, under 510(k) number K812676.

Who is the listed applicant for AMPLITONE-3?

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

What is the FDA product code for AMPLITONE-3?

The FDA product code for AMPLITONE-3 is LDE.

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 Progressive Technology, 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.

K902390AURA CERAMIC DENTAL APPLIANCE

Related Devices (Code: LDE)

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.

K945082CYPRESS MEDICAL PRODUCTS STETHOSCOPECypress Medical Products, Ltd.K944337VARIOUS STETHOSCOPESRud Riester GmbH & CO KGK940578MANUAL STETOSCOPEBhs Intl., Inc.K935944PROSCOPES AND ADSCOPESAmerican Diagnostic Corp.K923327STETHOSCOPE COVERAnup Chakraborty Co.K924095TIMEOSCOPE AND FLEXISCOPEStethoscopes of America, 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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