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FDA 510(k)

ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE

K-Number: K911520 · 1991-08-02

ApplicantAndronic Devices, Ltd.
Decision Date1991-08-02
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Andronic Devices, Ltd.. It received FDA 510(k) clearance on 1991-08-02 under 510(k) number K911520. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE?

ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE is a medical device that received FDA 510(k) clearance on 1991-08-02. The listed applicant is Andronic Devices, Ltd.. The 510(k) number is K911520.

When did ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE receive FDA 510(k) clearance?

ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE received FDA 510(k) clearance on 1991-08-02, under 510(k) number K911520.

Who is the listed applicant for ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE?

The FDA 510(k) record lists Andronic Devices, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE?

The FDA product code for ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE is KKX.

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Other records listing Andronic Devices, Ltd. as applicant

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.

K940812INSIGHT ELECTRONIC ALIGNMENT INDICATORK934926INSITE MODEL 20 & MODEL 15 INSUFFLATORSK934928INSITE FILTER & TUBING SETK935381KAPS POSITIONING ARMK934124AUTOQUOT AUTOMATED ALIQUOTTING SYSTEMK936308ENDEX ENDOSCOPIC POSITIONING SYSTEM

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Related Devices (Code: KKX)

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.

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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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