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FDA 510(k)

SYSTEM5RH STATIONARY EXERCISE BICYCLE

K-Number: K881475 · 1988-08-02

ApplicantCombi Co. Ltd., C/O Mitsui & Co. U.S.A., Inc.
Decision Date1988-08-02
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SYSTEM5RH STATIONARY EXERCISE BICYCLE is the device name listed in this FDA 510(k) record. The listed applicant is Combi Co. Ltd., C/O Mitsui & Co. U.S.A., Inc.. It received FDA 510(k) clearance on 1988-08-02 under 510(k) number K881475. 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 SYSTEM5RH STATIONARY EXERCISE BICYCLE?

SYSTEM5RH STATIONARY EXERCISE BICYCLE is a medical device that received FDA 510(k) clearance on 1988-08-02. The listed applicant is Combi Co. Ltd., C/O Mitsui & Co. U.S.A., Inc.. The 510(k) number is K881475.

When did SYSTEM5RH STATIONARY EXERCISE BICYCLE receive FDA 510(k) clearance?

SYSTEM5RH STATIONARY EXERCISE BICYCLE received FDA 510(k) clearance on 1988-08-02, under 510(k) number K881475.

Who is the listed applicant for SYSTEM5RH STATIONARY EXERCISE BICYCLE?

The FDA 510(k) record lists Combi Co. Ltd., C/O Mitsui & Co. U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYSTEM5RH STATIONARY EXERCISE BICYCLE?

The FDA product code for SYSTEM5RH STATIONARY EXERCISE BICYCLE is DPS.

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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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