FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SMDIA-1000
K Number: K101953
·
Decision Jan 7, 2011
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
507
Applicant Total
10
Review Days
179
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Basic Information
- Device Name
- SMDIA-1000
- K Number
- K101953
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Southmedic, Inc.
- Date Received
- July 12, 2010
- Decision Date
- January 7, 2011
- Product Code
- CAF
- 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 |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | FDA class 2 | Anesthesiology |
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|---|---|---|---|
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| K014211 | OXYARM CO2 | Jun 11, 2002 | Substantially Equivalent |
| K945993 | VAPOFIL | Feb 22, 1995 | Substantially Equivalent |
| K923265 | FUNNEL ADAPTOR | Mar 18, 1993 | Substantially Equivalent |
| K863318 | AEROSOL-T | Sep 11, 1986 | Substantially Equivalent |
| K861839 | VAPOFIL | May 21, 1986 | Substantially Equivalent |
| K860545 | VAPORIZER SPACER | Apr 17, 1986 | Substantially Equivalent |
| K843993 | ANAESLOCK THREE VAPORIZER INTERLOCK HVA003 | Nov 15, 1984 | Substantially Equivalent |