FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRIP TONOMETRY CATHETER, 14F
K Number: K993296
·
Decision Dec 15, 1999
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
58
Review Days
75
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Basic Information
- Device Name
- TRIP TONOMETRY CATHETER, 14F
- K Number
- K993296
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Datex-Ohmeda, Inc.
- Date Received
- October 1, 1999
- Decision Date
- December 15, 1999
- Product Code
- KNT
- 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Datex-Ohmeda, Inc.
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|---|---|---|---|
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| K170872 | Aisys CS2 | Aug 15, 2017 | Substantially Equivalent |
| K151570 | Carestation 620/650/650C | Jan 21, 2016 | Substantially Equivalent |
| K142679 | CARESCAPE R860 | Jun 12, 2015 | Substantially Equivalent |
| K143530 | Aespire View | Apr 24, 2015 | Substantially Equivalent |
| K140575 | ENGSTROM CARESTATION, ENGSTROM PRO | Feb 3, 2015 | Substantially Equivalent |