FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRACH MASK MODEL (245, 246)
K Number: K955483
·
Decision Feb 28, 1996
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
18
Applicant Total
27
Review Days
89
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Basic Information
- Device Name
- TRACH MASK MODEL (245, 246)
- K Number
- K955483
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5600
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hospitak, Inc.
- Date Received
- December 1, 1995
- Decision Date
- February 28, 1996
- 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
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|---|---|---|---|
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| 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 |
| K843212 | LOW PRESSURE ALARM FOR OXYGEN CYLINDER | Sep 19, 1984 | Substantially Equivalent |