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FDA 510(k)

SPR PLUS II OVERLAY SYSTEM (CL250/CL212

K-Number: K961854 · 1996-08-09

ApplicantGaymar Industries, Inc.
Decision Date1996-08-09
Product CodeFNM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SPR PLUS II OVERLAY SYSTEM (CL250/CL212 is the device name listed in this FDA 510(k) record. The listed applicant is Gaymar Industries, Inc.. It received FDA 510(k) clearance on 1996-08-09 under 510(k) number K961854. The device is classified under product code FNM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPR PLUS II OVERLAY SYSTEM (CL250/CL212?

SPR PLUS II OVERLAY SYSTEM (CL250/CL212 is a medical device that received FDA 510(k) clearance on 1996-08-09. The listed applicant is Gaymar Industries, Inc.. The 510(k) number is K961854.

When did SPR PLUS II OVERLAY SYSTEM (CL250/CL212 receive FDA 510(k) clearance?

SPR PLUS II OVERLAY SYSTEM (CL250/CL212 received FDA 510(k) clearance on 1996-08-09, under 510(k) number K961854.

Who is the listed applicant for SPR PLUS II OVERLAY SYSTEM (CL250/CL212?

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

What is the FDA product code for SPR PLUS II OVERLAY SYSTEM (CL250/CL212?

The FDA product code for SPR PLUS II OVERLAY SYSTEM (CL250/CL212 is FNM.

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Other records listing Gaymar Industries, Inc. as applicant

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Related Devices (Code: FNM)

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K973169PRESSURE GUARD SITE SELECT (A)Span-America Medical Systems, Inc.K972022ZAK-2000Cardio Systems, Inc.K974319MIGHTY AIRWheelchairs of KansasK974070PHYSIO/1000Physio Designs, Inc.K972549SIMPULSEKinetic Concepts, Inc.K970081SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEMCathay Consolidated, 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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