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FDA 510(k)

BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP

K-Number: K951770 · 1995-11-16

ApplicantBiodex Medical Systems, Inc.
Decision Date1995-11-16
Product CodeIKK
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP 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 1995-11-16 under 510(k) number K951770. The device is classified under product code IKK. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP?

BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP is a medical device that received FDA 510(k) clearance on 1995-11-16. The listed applicant is Biodex Medical Systems, Inc.. The 510(k) number is K951770.

When did BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP receive FDA 510(k) clearance?

BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP received FDA 510(k) clearance on 1995-11-16, under 510(k) number K951770.

Who is the listed applicant for BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP?

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 BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP?

The FDA product code for BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP is IKK.

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Other records listing Biodex Medical Systems, Inc. as applicant

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Related Devices (Code: IKK)

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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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