FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUTOMATIC TUBING CLAMP
K Number: K914459
·
Decision Jun 24, 1992
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
3
Applicant Total
5
Review Days
261
Basic Information
- Device Name
- AUTOMATIC TUBING CLAMP
- K Number
- K914459
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Rocky Mountain Research, Inc.
- Date Received
- October 7, 1991
- Decision Date
- June 24, 1992
- Product Code
- FIG
- 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 |
|---|---|---|---|
| FIG | Clamp, Tubing, Blood, Automatic | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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Other Clearances by Rocky Mountain Research, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K992857 | LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070 | Nov 10, 1999 | Substantially Equivalent |
| K961364 | AUTOMATIC TUBING CLAMP SYSTEM (ATC) | Oct 31, 1996 | Substantially Equivalent |
| K961598 | ELS AUTOMATIC TUBING CLAMP SYSTEM | Oct 29, 1996 | Substantially Equivalent |
| K921993 | ELS AUTOMATIC TUBING CLAMP SYSTEM | Jan 5, 1994 | Substantially Equivalent |