FDA 510(k)

STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT

K-Number: K972367 · 1997-09-04

Decision Date1997-09-04

Product CodeKIJ

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 1997-09-04 under 510(k) number K972367. The device is classified under product code KIJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT?

STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT is a medical device that received FDA 510(k) clearance on 1997-09-04. The listed applicant is Stryker Instruments. The 510(k) number is K972367.

When did STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT receive FDA 510(k) clearance?

STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT received FDA 510(k) clearance on 1997-09-04, under 510(k) number K972367.

Who is the listed applicant for STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT?

The FDA 510(k) record lists Stryker Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT?

The FDA product code for STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT is KIJ.

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Related Devices (Code: KIJ)

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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.