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FDA 510(k)

PCX-100 PATIENT INPUT LEADWIRE

K-Number: K851632 · 1985-11-08

ApplicantEaton Medical Group
Decision Date1985-11-08
Product CodeDRW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PCX-100 PATIENT INPUT LEADWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Eaton Medical Group. It received FDA 510(k) clearance on 1985-11-08 under 510(k) number K851632. The device is classified under product code DRW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PCX-100 PATIENT INPUT LEADWIRE?

PCX-100 PATIENT INPUT LEADWIRE is a medical device that received FDA 510(k) clearance on 1985-11-08. The listed applicant is Eaton Medical Group. The 510(k) number is K851632.

When did PCX-100 PATIENT INPUT LEADWIRE receive FDA 510(k) clearance?

PCX-100 PATIENT INPUT LEADWIRE received FDA 510(k) clearance on 1985-11-08, under 510(k) number K851632.

Who is the listed applicant for PCX-100 PATIENT INPUT LEADWIRE?

The FDA 510(k) record lists Eaton Medical Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PCX-100 PATIENT INPUT LEADWIRE?

The FDA product code for PCX-100 PATIENT INPUT LEADWIRE is DRW.

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Other records listing Eaton Medical Group 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.

K851623MODEL TRC-40 TELEMETRY RECIEVER MODULEK851624MODEL TT-185 TELEMETRY TRANSMITTERK851625SCX-10 SINGLE CHANNEL RECORDER ACCESS. FOR G-2000K851627KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTRK851631TMX-C1/C2 TRADMILL CONTROLLER ACCESS.K851630TMX-80 TREADMILL

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Related Devices (Code: DRW)

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.

K033513EASI ECG ALGORITHMPhilips Medical SystemsK020456EASI 12 LEAD ALGORITHMPhilips Medical SystemsK930786EPCORSiemens Medical Solutions USA, Inc.K872781EASI LEAD SYSTEM CABLE ASSEMBLYTotemite Medical ElectronicsK861981ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTORVital Signs, Inc.K851627KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTREaton Medical Group

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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