FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SATELLITE K+ BLOOD POTASSIUM MONITORING SYSTEM
K Number: K897110
·
Decision Feb 27, 1990
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
88
Applicant Total
15
Review Days
63
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Basic Information
- Device Name
- SATELLITE K+ BLOOD POTASSIUM MONITORING SYSTEM
- K Number
- K897110
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1600
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Medisense, Inc.
- Date Received
- December 26, 1989
- Decision Date
- February 27, 1990
- Product Code
- CEM
- 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 |
|---|---|---|---|
| CEM | Electrode, Ion Specific, Potassium | FDA class 2 | Clinical Chemistry |
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Other Clearances by Medisense, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K983504 | PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST ST | Jul 9, 1999 | Substantially Equivalent |
| K982303 | PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST | Dec 8, 1998 | Substantially Equivalent |
| K983253 | PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT | Nov 20, 1998 | Substantially Equivalent |
| K971812 | PRECISION QID BLOOD GLUCOSE TEST STRIP, PRECISION G BLOOD GLUCOSE TEST STRIP | Aug 8, 1997 | Substantially Equivalent |
| K963676 | PRECISION G BLOOD GLUCOSE TESTING SYSTEM | Feb 20, 1997 | Substantially Equivalent |
| K962295 | PRECISION QID BLOOD GLUCOSE TEST STRIP | Jul 26, 1996 | Substantially Equivalent |
| K961337 | EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM | Jun 21, 1996 | Substantially Equivalent |
| K952279 | PRECISION LINK BLOOD GLUCOSE DATA MANAGEMENT SYSTEM | Jun 14, 1995 | Substantially Equivalent |
| K944195 | QUICKPRO BLOOD GLUCOSE TESTING SYSTEM | Mar 23, 1995 | Substantially Equivalent |
| K945887 | PRECISION Q I D BLOOD GLUCOSE TEST STRIPS | Mar 23, 1995 | Substantially Equivalent |