FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
URINARY BLADDER TEMP. SENSOR #81-003
K Number: K823077
·
Decision Mar 9, 1983
Classifications
1
FEI Numbers
488
Registration Numbers
488
Same Product Code
797
Applicant Total
12
Review Days
141
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Basic Information
- Device Name
- URINARY BLADDER TEMP. SENSOR #81-003
- K Number
- K823077
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Clinical Technology Corp.
- Date Received
- October 19, 1982
- Decision Date
- March 9, 1983
- Product Code
- FLL
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | FDA class 2 | General Hospital |
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Other Clearances by Clinical Technology Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K925080 | TEK-LUBE | Jan 31, 1994 | Substantially Equivalent |
| K872867 | BIOSIGN | Jul 6, 1988 | Substantially Equivalent |
| K880166 | BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000 | Feb 18, 1988 | Substantially Equivalent |
| K872705 | BOVIE 400-CT ELECTROSURGICAL GENERATOR (UNIT) | Sep 1, 1987 | Substantially Equivalent |
| K855138 | BOVIE ULTRASONIC SURGICAL SYSTEM | Nov 10, 1986 | Substantially Equivalent |
| K854231 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE/ACCES | May 2, 1986 | Substantially Equivalent |
| K853507 | STERI-GRIP | Sep 5, 1985 | Substantially Equivalent |
| K852986 | GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN | Aug 19, 1985 | Substantially Equivalent |
| K844565 | BOVIE X-10 ELECTROSURGICAL GENERATOR(UNIT) | Feb 21, 1985 | Substantially Equivalent |
| K841272 | SICKLE-STAT HEMOGLOBIN S SCREEN KIT | Apr 13, 1984 | Substantially Equivalent |