FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MARKII VENTIMASKS
K Number: K781325
·
Decision Sep 27, 1978
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
18
Applicant Total
22
Review Days
57
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
- MARKII VENTIMASKS
- K Number
- K781325
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5600
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Vickers America Medical Corp.
- Date Received
- August 1, 1978
- Decision Date
- September 27, 1978
- 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
VENTIMASK MK IV
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
Other Clearances by Vickers America Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K840823 | TREONIC C30 | Mar 23, 1984 | Substantially Equivalent |
| K831838 | LABORATORY DATA MGMT SYSTEM SDMS | Jan 24, 1984 | Substantially Equivalent |
| K830748 | RESUSCITAIRE | Jun 22, 1983 | Substantially Equivalent |
| K830936 | TREONIC IP5 | Apr 12, 1983 | Substantially Equivalent |
| K813239 | OXYGENAIRE NURING INCUBATOR | Jan 28, 1982 | Substantially Equivalent |
| K813238 | NEOCARE BABY-CONTROLLED INCUBATOR | Jan 22, 1982 | Substantially Equivalent |
| K811865 | VMA PEDIATRIC APNEA MATTRESS | Jul 31, 1981 | Substantially Equivalent |
| K810792 | NEOCARE TEMPERATURE MONITOR | Apr 29, 1981 | Substantially Equivalent |
| K810067 | 140 NEOCARE AIR CONTROLLED INCUBATOR | Mar 11, 1981 | Substantially Equivalent |
| K810571 | NEOCARE OXYGEN MONITOR | Mar 11, 1981 | Substantially Equivalent |