FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIMEX SUBGLOTTIC ASPIRATION SYSTEM
K Number: K141255
·
Decision Sep 22, 2014
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
158
Applicant Total
3
Review Days
131
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Basic Information
- Device Name
- SIMEX SUBGLOTTIC ASPIRATION SYSTEM
- K Number
- K141255
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Simex Medizintechnik GmbH
- Date Received
- May 14, 2014
- Decision Date
- September 22, 2014
- Product Code
- BTA
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | FDA class 2 | General, Plastic Surgery |
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