Vmate Model VMM1000

Q: What is the product code of K030948?

The FDA product code is HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4150.

FDA 510(k) K030948 · Howard Instruments, Inc.

Substantially Equivalent

510(k) numberK030948

Submission

Device name: Vmate Model VMM1000
Applicant: Howard Instruments, Inc.
Tuscaloosa, AL, US
Received: March 26, 2003
Decision date: June 17, 2003
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Device class: Class II (moderate risk)
Regulation: 21 CFR 886.4150
Specialty: Ophthalmic

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K033390	Colibri Disposable Vitrectomy CutterHQE · Traditional	Microworld Medical Instruments, Inc.	11/04/2003SE
K023939	Velocity AdvantageHQE · Traditional	Visioncare Devices, Inc.	04/17/2003SE
K020911	Mid Labs Autonomous Vit Enhancer (Ave)HQE · Traditional	Medical Instrument Development Laboratories, Inc.	04/29/2002SE

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Questions and answers

When was Vmate Model VMM1000 cleared by the FDA?

Vmate Model VMM1000 (K030948) received a 510(k) decision of Substantially Equivalent on June 17, 2003, 83 days after the submission was received.

What is the product code of K030948?

The FDA product code is HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4150.