FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
DILECTRON URINARY CONDUCTIVITY PROBE
K Number: K891681
·
Decision May 1, 1990
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
12
Applicant Total
8
Review Days
405
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Basic Information
- Device Name
- DILECTRON URINARY CONDUCTIVITY PROBE
- K Number
- K891681
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2800
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Gyrus Medical , Ltd.
- Date Received
- March 22, 1989
- Decision Date
- May 1, 1990
- Product Code
- JRE
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JRE | Refractometer For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Gyrus Medical , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K041285 | GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) | Sep 10, 2004 | Substantially Equivalent |
| K003569 | PLASMAKINETIC ENDOUROLOGY SYSTEM | Dec 19, 2000 | Substantially Equivalent |
| K001270 | GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE | Apr 28, 2000 | Substantially Equivalent |
| K994166 | GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE | Dec 27, 1999 | Substantially Equivalent |
| K993749 | GYRUS HYSTEROSCOPIC RESECTOSCOPE | Dec 3, 1999 | Substantially Equivalent |
| K990628 | GYRUS ENDOUROLOGY SYSTEM | Jun 29, 1999 | Substantially Equivalent |
| K982771 | GYRUS HYSTEROSCOPIC RESECTOSCOPE | Jan 21, 1999 | Substantially Equivalent |