FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
VAPOFIL
K Number: K945993
·
Decision Feb 22, 1995
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
56
Applicant Total
10
Review Days
96
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- VAPOFIL
- K Number
- K945993
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5880
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Southmedic, Inc.
- Date Received
- November 18, 1994
- Decision Date
- February 22, 1995
- Product Code
- CAD
- 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 |
|---|---|---|---|
| CAD | Vaporizer, Anesthesia, Non-Heated | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAD), ordered by most recent decision date.
V80 Anesthetic Vaporizer (V80)
FDA 510(k)
FDA Class 2
·Anesthesiology
Tec 820, Tec 850
FDA 510(k)
FDA Class 2
·Anesthesiology
V60 Anesthetic Vaporizer
FDA 510(k)
FDA Class 2
·Anesthesiology
SEVOFLURANE VAPORIZER ADAPTOR
FDA 510(k)
FDA Class 2
·Anesthesiology
SIGMA ALPHA VAPORIZER
FDA 510(k)
FDA Class 2
·Anesthesiology
KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Southmedic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K222511 | Oxy2Pro | Nov 21, 2023 | Substantially Equivalent |
| K131410 | CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 (10CM) CO2 TUBE), | Jan 13, 2014 | Substantially Equivalent |
| K101953 | SMDIA-1000 | Jan 7, 2011 | Substantially Equivalent |
| K014211 | OXYARM CO2 | Jun 11, 2002 | 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 |