FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
AEROSOL-T
K Number: K863318
·
Decision Sep 11, 1986
Classifications
1
FEI Numbers
167
Registration Numbers
167
Same Product Code
93
Applicant Total
10
Review Days
16
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Basic Information
- Device Name
- AEROSOL-T
- K Number
- K863318
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Southmedic, Inc.
- Date Received
- August 26, 1986
- Decision Date
- September 11, 1986
- Product Code
- BZA
- 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 |
|---|---|---|---|
| BZA | Connector, Airway (Extension) | FDA class 1 | Anesthesiology |
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|---|---|---|---|
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| K101953 | SMDIA-1000 | Jan 7, 2011 | Substantially Equivalent |
| K014211 | OXYARM CO2 | Jun 11, 2002 | Substantially Equivalent |
| K945993 | VAPOFIL | Feb 22, 1995 | Substantially Equivalent |
| K923265 | FUNNEL ADAPTOR | Mar 18, 1993 | 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 |