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FDA 510(k)

FISIO CHAMBER SPACE

K-Number: K101136 · 2011-01-28

ApplicantKoo (Shanghai) Industries Co., Ltd.
Decision Date2011-01-28
Product CodeNVP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FISIO CHAMBER SPACE is the device name listed in this FDA 510(k) record. The listed applicant is Koo (Shanghai) Industries Co., Ltd.. It received FDA 510(k) clearance on 2011-01-28 under 510(k) number K101136. The device is classified under product code NVP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FISIO CHAMBER SPACE?

FISIO CHAMBER SPACE is a medical device that received FDA 510(k) clearance on 2011-01-28. The listed applicant is Koo (Shanghai) Industries Co., Ltd.. The 510(k) number is K101136.

When did FISIO CHAMBER SPACE receive FDA 510(k) clearance?

FISIO CHAMBER SPACE received FDA 510(k) clearance on 2011-01-28, under 510(k) number K101136.

Who is the listed applicant for FISIO CHAMBER SPACE?

The FDA 510(k) record lists Koo (Shanghai) Industries Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FISIO CHAMBER SPACE?

The FDA product code for FISIO CHAMBER SPACE is NVP.

Related Clinical Trials

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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Other records listing Koo (Shanghai) Industries Co., 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.

K112041KOO SMALL VOLUME NEBULIZER (SVN)

Related Devices (Code: NVP)

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.

K242667AeroChamber2go Anti-Static Valved Holding ChamberTrudell Medical InternationalK210558LiteAire Basic Dual-Valved, Collapsible MDI Holding ChamberThayer Medical CorporationK181649AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)Trudell Medical InternationalK160109Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding ChamberThayer Medical CorporationK143615Antistatic Compact Space ChamberMedical Developments International LimitedK122252SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUSMedical Developments International

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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