FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MANIFOLD/NEBULIZER BREATHING PRODUCTS
K Number: K791469
·
Decision Aug 28, 1979
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
87
Applicant Total
27
Review Days
22
Basic Information
- Device Name
- MANIFOLD/NEBULIZER BREATHING PRODUCTS
- K Number
- K791469
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5975
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- HOSPITAK, INC.
- Date Received
- August 6, 1979
- Decision Date
- August 28, 1979
- Product Code
- BZO
- 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 |
|---|---|---|---|
| BZO | Set, Tubing And Support, Ventilator (W Harness) | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZO), ordered by most recent decision date.
UNICOR, INC. CORRUGATED TUBING
FDA 510(k)
FDA Class 1
·Anesthesiology
UNICOR, INC. VENTILATOR HOSES
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA BREATHING BAGS
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA VENTILATOR HOSES
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA CUSTOM ANESTESIA CIRCUIT
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA VOLUMN VENTILATORSS
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by HOSPITAK, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K955483 | TRACH MASK MODEL (245, 246) | Feb 28, 1996 | Substantially Equivalent |
| K954787 | ILLUMINATOR | Jan 31, 1996 | Substantially Equivalent |
| K953620 | WARM N WET HMEF W/LUER ADAPTER | Aug 25, 1995 | Substantially Equivalent |
| K953619 | WARM N WET HME W/LUER ADAPTER | Aug 25, 1995 | Substantially Equivalent |
| K915750 | DISPOSABLE BACTERIAL BREATHNG FILTER | Nov 30, 1994 | Substantially Equivalent |
| K920842 | AEROSOL DELIVERY SYSTEMS | May 15, 1992 | Substantially Equivalent |
| K915228 | DISPOSABLE CO2 GAS SAMPLING/OXYGEN DELIVERY CANNUL | Feb 11, 1992 | Substantially Equivalent |
| K873286 | DISPOSABLE, MANUAL PULMONARY RESUSCITATOR | Oct 26, 1987 | Substantially Equivalent |
| K853600 | INFLATABLE AIR SPLINTS | Sep 19, 1985 | Substantially Equivalent |
| K844328 | OXYGEN CONCENTRATOR | Dec 4, 1984 | Substantially Equivalent |