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FDA 510(k)

SEMI-RECUMBENT CYCLES

K-Number: K935216 · 1994-09-16

ApplicantBiodex Medical Systems, Inc.
Decision Date1994-09-16
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SEMI-RECUMBENT CYCLES is the device name listed in this FDA 510(k) record. The listed applicant is Biodex Medical Systems, Inc.. It received FDA 510(k) clearance on 1994-09-16 under 510(k) number K935216. The device is classified under product code BXB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEMI-RECUMBENT CYCLES?

SEMI-RECUMBENT CYCLES is a medical device that received FDA 510(k) clearance on 1994-09-16. The listed applicant is Biodex Medical Systems, Inc.. The 510(k) number is K935216.

When did SEMI-RECUMBENT CYCLES receive FDA 510(k) clearance?

SEMI-RECUMBENT CYCLES received FDA 510(k) clearance on 1994-09-16, under 510(k) number K935216.

Who is the listed applicant for SEMI-RECUMBENT CYCLES?

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

What is the FDA product code for SEMI-RECUMBENT CYCLES?

The FDA product code for SEMI-RECUMBENT CYCLES is BXB.

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Other records listing Biodex Medical Systems, Inc. as applicant

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K090296ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336K063666SHARPS CONTAINER, MODEL 039-413K951770BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3APK950981ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650K942694STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302K940301COMPEX 2

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Related Devices (Code: BXB)

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.

K072887G-TRAINER MEDICALAlter-G, Inc.K003272FLO-BOOTDiscovery Group, LLCK952975ANKLE CALF EXERCISER PHLEBOPUMPPrevent Products, Inc.K953456E-Z FLEXFluid Motion Biotechnologies, Inc.K955106BTE CPM-20Baltimore Therapeutic Equipment Co.K955105BTE CPM-10Baltimore Therapeutic Equipment Co.

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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