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FDA 510(k)

IMPALA

K-Number: K913512 · 1991-08-29

ApplicantPin Dot Products, Inc.
Decision Date1991-08-29
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

IMPALA is the device name listed in this FDA 510(k) record. The listed applicant is Pin Dot Products, Inc.. It received FDA 510(k) clearance on 1991-08-29 under 510(k) number K913512. 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 IMPALA?

IMPALA is a medical device that received FDA 510(k) clearance on 1991-08-29. The listed applicant is Pin Dot Products, Inc.. The 510(k) number is K913512.

When did IMPALA receive FDA 510(k) clearance?

IMPALA received FDA 510(k) clearance on 1991-08-29, under 510(k) number K913512.

Who is the listed applicant for IMPALA?

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

What is the FDA product code for IMPALA?

The FDA product code for IMPALA is IOR.

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Other records listing Pin Dot Products, 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.

K925258DYNAMIC PRESSURE MONITOR 2000M AND 2000CK913510MECHANICAL SHAPE SENSORK913509IMPALA WHEELSK913553PIN DOT GROWTH/DIAL LINKSK913548PIN DOT ALUMINUM PANK913511IMPALA AXLES

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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

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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