FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VMATE MODEL VMM1000
K Number: K030948
·
Decision Jun 17, 2003
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
148
Applicant Total
5
Review Days
83
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- VMATE MODEL VMM1000
- K Number
- K030948
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4150
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Howard Instruments, Inc.
- Date Received
- March 26, 2003
- Decision Date
- June 17, 2003
- Product Code
- HQE
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HQE), ordered by most recent decision date.
UniVit HE, UniVit UHS
FDA 510(k)
FDA Class 2
·Ophthalmic
Cetus system, Cetus probe
FDA 510(k)
FDA Class 2
·Ophthalmic
Bi-Blade Vitrectomy Cutter
FDA 510(k)
FDA Class 2
·Ophthalmic
CONSTELLATION VISION SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
VERSAVIT
FDA 510(k)
FDA Class 2
·Ophthalmic
PROCARE PLUS VITRECTOMY SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic