FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BETA MULTI-PROCEDURE MOBILE UROLOGICAL TABLE, MODEL S5005
K Number: K954278
·
Decision Oct 2, 1995
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
3
Applicant Total
1
Review Days
19
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
- BETA MULTI-PROCEDURE MOBILE UROLOGICAL TABLE, MODEL S5005
- K Number
- K954278
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4890
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Beta Medical Products, Inc.
- Date Received
- September 13, 1995
- Decision Date
- October 2, 1995
- Product Code
- MMZ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| MMZ | Table, Cystometric, Electric | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MMZ), ordered by most recent decision date.
LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYNERGY II
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MDT UROLOGY TABLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology