FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SMARTMONITOR 2, MODEL 4000
K Number: K011597
·
Decision Jan 11, 2002
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
15
Applicant Total
2
Review Days
232
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Basic Information
- Device Name
- SMARTMONITOR 2, MODEL 4000
- K Number
- K011597
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 868.2377
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Respironics Georgia, Inc.
- Date Received
- May 24, 2001
- Decision Date
- January 11, 2002
- Product Code
- FLS
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| FLS | Monitor, Apnea, Facility Use | FDA class 2 | Anesthesiology |
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Other Clearances by Respironics Georgia, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K001708 | PROFOX SOFTWARE, MODEL 920M-41 | Mar 1, 2001 | Substantially Equivalent |