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FDA 510(k)

BIOVALVE MINI-JECT NEEDLEFREE INJECTOR

K-Number: K051985 · 2005-08-17

ApplicantBiovalve Technologies, Inc.
Decision Date2005-08-17
Product CodeKZE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BIOVALVE MINI-JECT NEEDLEFREE INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Biovalve Technologies, Inc.. It received FDA 510(k) clearance on 2005-08-17 under 510(k) number K051985. The device is classified under product code KZE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOVALVE MINI-JECT NEEDLEFREE INJECTOR?

BIOVALVE MINI-JECT NEEDLEFREE INJECTOR is a medical device that received FDA 510(k) clearance on 2005-08-17. The listed applicant is Biovalve Technologies, Inc.. The 510(k) number is K051985.

When did BIOVALVE MINI-JECT NEEDLEFREE INJECTOR receive FDA 510(k) clearance?

BIOVALVE MINI-JECT NEEDLEFREE INJECTOR received FDA 510(k) clearance on 2005-08-17, under 510(k) number K051985.

Who is the listed applicant for BIOVALVE MINI-JECT NEEDLEFREE INJECTOR?

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

What is the FDA product code for BIOVALVE MINI-JECT NEEDLEFREE INJECTOR?

The FDA product code for BIOVALVE MINI-JECT NEEDLEFREE INJECTOR is KZE.

Related Clinical Trials

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Other records listing Biovalve Technologies, 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.

K050971BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS)K032976BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001

Related Devices (Code: KZE)

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.

K121270BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEMBioject Medical Technologies, Inc.K111517PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATIPharmajet, Inc.K110456PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEMPharmajet, Inc.K090959LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RAD'Antonio Consultants International, Inc. (Dci)K090003ZETAJETBioject, Inc.K081532PHARMAJET NEEDLE-FREE INJECTION SYSTEMPharmajet, Inc.

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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