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FDA 510(k)

PANDA

K-Number: K923428 · 1993-03-04

ApplicantEtac Us, Inc.
Decision Date1993-03-04
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PANDA is the device name listed in this FDA 510(k) record. The listed applicant is Etac Us, Inc.. It received FDA 510(k) clearance on 1993-03-04 under 510(k) number K923428. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PANDA?

PANDA is a medical device that received FDA 510(k) clearance on 1993-03-04. The listed applicant is Etac Us, Inc.. The 510(k) number is K923428.

When did PANDA receive FDA 510(k) clearance?

PANDA received FDA 510(k) clearance on 1993-03-04, under 510(k) number K923428.

Who is the listed applicant for PANDA?

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

What is the FDA product code for PANDA?

The FDA product code for PANDA is IOR.

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Related PubMed Literature

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.

PMID: 32094048US Food and Drug Administration and Off-Label Use of Metal Expandable Biliary Stents within the Peripheral Vasculature-Update.Journal of vascular and interventional radiology : JVIR ()

Other records listing Etac Us, Inc. 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.

K914610SWEDE CROSS MANUAL WHEELCHAIRK883275SWEDE ELITE, MECHANICAL WHEELCHAIRK875035SWEDE PETITE (WHEELCHAIR)K875034SWEDE CHAMP (WHEELCHAIR)

Related Devices (Code: IOR)

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.

K253762ErgoSteel (ES0001/696)Strongback Mobility AG C/O Blueaudit GmbHK261919Multifunctional wheelchair (YJ-059)Zhenjiang Assure Medical Equipment Co., Ltd.K260141Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)Zhenjiang Assure Medical Equipment Co., Ltd.K260145YJ-K1K2 Wheelchair (YJ-013F)Zhenjiang Assure Medical Equipment Co., Ltd.K260144Reclining wheelchair (YJ-013L)Zhenjiang Assure Medical Equipment Co., Ltd.K261571Manual Wheelchair (H008, PCK7)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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