FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNERGY II
K Number: K942445
·
Decision Nov 22, 1994
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
3
Applicant Total
5
Review Days
183
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Basic Information
- Device Name
- SYNERGY II
- K Number
- K942445
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4890
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Synectics Medical, Inc.
- Date Received
- May 23, 1994
- Decision Date
- November 22, 1994
- 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 |
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