FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIGMOID TONOMITOR
K Number: K890466
·
Decision Apr 21, 1989
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
4
Review Days
80
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Basic Information
- Device Name
- SIGMOID TONOMITOR
- K Number
- K890466
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Tonometrics, Inc.
- Date Received
- January 31, 1989
- Decision Date
- April 21, 1989
- Product Code
- GBT
- 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 |
|---|---|---|---|
| GBT | Catheter, Rectal | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GBT), ordered by most recent decision date.
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