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FDA 510(k)

SCHILLER EKG COMBI MSG-IM SCOPE & RECORDER

K-Number: K852281 · 1985-10-09

ApplicantArmstrong Ind., Inc.
Decision Date1985-10-09
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCHILLER EKG COMBI MSG-IM SCOPE & RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Armstrong Ind., Inc.. It received FDA 510(k) clearance on 1985-10-09 under 510(k) number K852281. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCHILLER EKG COMBI MSG-IM SCOPE & RECORDER?

SCHILLER EKG COMBI MSG-IM SCOPE & RECORDER is a medical device that received FDA 510(k) clearance on 1985-10-09. The listed applicant is Armstrong Ind., Inc.. The 510(k) number is K852281.

When did SCHILLER EKG COMBI MSG-IM SCOPE & RECORDER receive FDA 510(k) clearance?

SCHILLER EKG COMBI MSG-IM SCOPE & RECORDER received FDA 510(k) clearance on 1985-10-09, under 510(k) number K852281.

Who is the listed applicant for SCHILLER EKG COMBI MSG-IM SCOPE & RECORDER?

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

What is the FDA product code for SCHILLER EKG COMBI MSG-IM SCOPE & RECORDER?

The FDA product code for SCHILLER EKG COMBI MSG-IM SCOPE & RECORDER is DPS.

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 Armstrong Ind., 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.

K852181ELECTROCARDIOGRAPHK852282SCHILLER MINISCOPE MS-2 EKG SCOPEK851705LARYNGOSCOPEK822727RESCUER

Related Devices (Code: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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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