FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ONETOUCH REVEAL
K Number: K132618
·
Decision Dec 16, 2013
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
47
Applicant Total
42
Review Days
117
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Basic Information
- Device Name
- ONETOUCH REVEAL
- K Number
- K132618
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lifescan, Inc.
- Date Received
- August 21, 2013
- Decision Date
- December 16, 2013
- Product Code
- MRZ
- 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 |
|---|---|---|---|
| MRZ | Accessories, Pump, Infusion | FDA class 2 | General Hospital |
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Other Clearances by Lifescan, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K120558 | ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION | Feb 7, 2013 | Substantially Equivalent |
| K093745 | ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM | Feb 11, 2011 | Substantially Equivalent |
| K082590 | SYMPHONY METER REMOTE | Dec 17, 2008 | Substantially Equivalent |
| K082513 | ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM | Oct 22, 2008 | Substantially Equivalent |
| K081318 | ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM | Jun 9, 2008 | Substantially Equivalent |
| K073231 | ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM | Apr 18, 2008 | Substantially Equivalent |
| K072543 | ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM | Oct 5, 2007 | Substantially Equivalent |
| K062195 | MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM | Aug 16, 2006 | Substantially Equivalent |
| K061118 | ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM | May 19, 2006 | Substantially Equivalent |
| K053529 | ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM | Jan 17, 2006 | Substantially Equivalent |