FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
M4 MONITOR
K Number: K110957
·
Decision May 31, 2011
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
46
Applicant Total
2
Review Days
56
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Basic Information
- Device Name
- M4 MONITOR
- K Number
- K110957
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spectrum Medical, Llp
- Date Received
- April 5, 2011
- Decision Date
- May 31, 2011
- Product Code
- DRY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by Spectrum Medical, Llp
| K Number | Device Name | ||
|---|---|---|---|
| K062468 | SPECTRUM M2 MONITOR | Sep 13, 2006 | Substantially Equivalent |