FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS, MIDWEST REPROCESSING CENTER REPROCESSED ALP SLE
K Number: K101330
·
Decision Aug 27, 2010
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
349
Applicant Total
4
Review Days
107
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Basic Information
- Device Name
- MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS, MIDWEST REPROCESSING CENTER REPROCESSED ALP SLE
- K Number
- K101330
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Midwest Reprocessing Center, LLC
- Date Received
- May 12, 2010
- Decision Date
- August 27, 2010
- Product Code
- JOW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | FDA class 2 | Cardiovascular |
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Other Clearances by Midwest Reprocessing Center, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K111007 | MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST RE | Jun 8, 2011 | Substantially Equivalent |
| K101280 | MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE | Oct 7, 2010 | Substantially Equivalent |
| K101702 | MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFS | Aug 27, 2010 | Substantially Equivalent |