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FDA 510(k)

TMX-80 TREADMILL

K-Number: K851630 · 1985-07-09

ApplicantEaton Medical Group
Decision Date1985-07-09
Product CodeIOL
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TMX-80 TREADMILL 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 1985-07-09 under 510(k) number K851630. The device is classified under product code IOL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TMX-80 TREADMILL?

TMX-80 TREADMILL is a medical device that received FDA 510(k) clearance on 1985-07-09. The listed applicant is Eaton Medical Group. The 510(k) number is K851630.

When did TMX-80 TREADMILL receive FDA 510(k) clearance?

TMX-80 TREADMILL received FDA 510(k) clearance on 1985-07-09, under 510(k) number K851630.

Who is the listed applicant for TMX-80 TREADMILL?

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 TMX-80 TREADMILL?

The FDA product code for TMX-80 TREADMILL is IOL.

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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-2000K851632PCX-100 PATIENT INPUT LEADWIREK851627KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTRK851631TMX-C1/C2 TRADMILL CONTROLLER ACCESS.

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Related Devices (Code: IOL)

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.

K950377PARKER MODEL PEParker Treadmill Co., Inc.K950376PARKER MODEL PMParker Treadmill Co., Inc.K925839TRACKMASTERJas Manufacturing Co., Inc.K930261RTM REHABILITATION TREADMILL, MODEL #945-200Biodan Medical Systems, Ltd.K904556MANSFIELD CARDIAC ASSIST MODEL 940(TM) IABBoston Scientific CorpK913518TA620 TREADMILL CONTROLLERSiemens Burdick, 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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