FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
VENTIMASK MK IV
K Number: K951652
·
Decision Apr 27, 1995
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
18
Applicant Total
7
Review Days
17
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
- VENTIMASK MK IV
- K Number
- K951652
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5600
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Flexicare Medical, Ltd.
- Date Received
- April 10, 1995
- Decision Date
- April 27, 1995
- Product Code
- BYF
- 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 |
|---|---|---|---|
| BYF | Mask, Oxygen, Low Concentration, Venturi | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYF), ordered by most recent decision date.
TRACH MASK MODEL (245, 246)
FDA 510(k)
FDA Class 1
·Anesthesiology
CARNATION TRACHEOSTOMY MASKS
FDA 510(k)
FDA Class 1
·Anesthesiology
VENTURI MASK/ADULT & PAEDIATRIC
FDA 510(k)
FDA Class 1
·Anesthesiology
VENTURI MASK W/HUMDIFICATION CUP ADULT/PAEDIATRIC
FDA 510(k)
FDA Class 1
·Anesthesiology
OXY-DIAL
FDA 510(k)
FDA Class 1
·Anesthesiology
DUAL DIAL VENTURI STYLE MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Flexicare Medical, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K150900 | Flexicare Heated Wire Breathing Systems | May 15, 2015 | Substantially Equivalent |
| K140473 | DUALGUARD | Apr 10, 2014 | Substantially Equivalent |
| K140113 | O2 NASAL CANNULA WITH CO2 MONITORING | Mar 6, 2014 | Substantially Equivalent |
| K132619 | CLASSIC INTERMITTENT CATHETER | Oct 11, 2013 | Substantially Equivalent |
| K092218 | FLEXICARE BREATHING FILTERS | Oct 6, 2009 | Substantially Equivalent |
| K091591 | FLEXICARE MEDICAL ENDOTRACHEAL TUBES | Jun 17, 2009 | Substantially Equivalent |