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FDA 510(k)

KOKO PEAK KP; KOKO PEAK KP+

K-Number: K010009 · 2001-06-01

ApplicantPds Healthcare Products, Inc.
Decision Date2001-06-01
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

KOKO PEAK KP; KOKO PEAK KP+ is the device name listed in this FDA 510(k) record. The listed applicant is Pds Healthcare Products, Inc.. It received FDA 510(k) clearance on 2001-06-01 under 510(k) number K010009. The device is classified under product code BZH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOKO PEAK KP; KOKO PEAK KP+?

KOKO PEAK KP; KOKO PEAK KP+ is a medical device that received FDA 510(k) clearance on 2001-06-01. The listed applicant is Pds Healthcare Products, Inc.. The 510(k) number is K010009.

When did KOKO PEAK KP; KOKO PEAK KP+ receive FDA 510(k) clearance?

KOKO PEAK KP; KOKO PEAK KP+ received FDA 510(k) clearance on 2001-06-01, under 510(k) number K010009.

Who is the listed applicant for KOKO PEAK KP; KOKO PEAK KP+?

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

What is the FDA product code for KOKO PEAK KP; KOKO PEAK KP+?

The FDA product code for KOKO PEAK KP; KOKO PEAK KP+ is BZH.

Other records listing Pds Healthcare 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.

K013489KP + LFM

Related Devices (Code: BZH)

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.

K253180Microlife Digital Peak Flow Meter, Model PF200B (PF200B)Microlife CorporationK252802Peak Flow Meter (PF-10(BR-PEF231))Shenzhen Bi-Rich Medical Devices Co., Ltd.K241338Peak Flow MeterChongqing Moffy Innovation Technology Co., Ltd.K232588Aluna 2Knox Medical DiagnosticsK230423Electronic Peak Flow MeterTaian Dalu Medical Instrument Co., Ltd.K222810TD-7301 Peak Flow meterGostar 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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