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FDA 510(k)

ADR-2000 AMBULATORY DATA RECORDING SYSTEM

K-Number: K880977 · 1988-04-13

ApplicantAaron Laboratories, Inc.
Decision Date1988-04-13
Product CodeIKN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ADR-2000 AMBULATORY DATA RECORDING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aaron Laboratories, Inc.. It received FDA 510(k) clearance on 1988-04-13 under 510(k) number K880977. The device is classified under product code IKN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADR-2000 AMBULATORY DATA RECORDING SYSTEM?

ADR-2000 AMBULATORY DATA RECORDING SYSTEM is a medical device that received FDA 510(k) clearance on 1988-04-13. The listed applicant is Aaron Laboratories, Inc.. The 510(k) number is K880977.

When did ADR-2000 AMBULATORY DATA RECORDING SYSTEM receive FDA 510(k) clearance?

ADR-2000 AMBULATORY DATA RECORDING SYSTEM received FDA 510(k) clearance on 1988-04-13, under 510(k) number K880977.

Who is the listed applicant for ADR-2000 AMBULATORY DATA RECORDING SYSTEM?

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

What is the FDA product code for ADR-2000 AMBULATORY DATA RECORDING SYSTEM?

The FDA product code for ADR-2000 AMBULATORY DATA RECORDING SYSTEM is IKN.

Related Clinical Trials

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Other records listing Aaron Laboratories, 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.

K880976AL-200B MUSCLE ACTIVITY INTEGRATOR

Related Devices (Code: IKN)

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.

K172743Natus VikingQuestNatus Neurology IncorporatedK163150ViMove2Dorsavi, Ltd.K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc.K123902PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)Oktx, LLCK123399MYOVISION 3.0 WIREFREE SYSTEMPrecision Biometrics, Inc.K113074CMAP PROMedical Technologies, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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