FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INFLATABLE AIR SPLINTS
K Number: K853600
·
Decision Sep 19, 1985
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
6
Applicant Total
27
Review Days
23
Basic Information
- Device Name
- INFLATABLE AIR SPLINTS
- K Number
- K853600
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.3900
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- HOSPITAK, INC.
- Date Received
- August 27, 1985
- Decision Date
- September 19, 1985
- Product Code
- FZF
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FZF | Splint, Extremity, Inflatable, External | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FZF), ordered by most recent decision date.
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|---|---|---|---|
| K955483 | TRACH MASK MODEL (245, 246) | Feb 28, 1996 | Substantially Equivalent |
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| 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 |
| K844328 | OXYGEN CONCENTRATOR | Dec 4, 1984 | Substantially Equivalent |
| K843212 | LOW PRESSURE ALARM FOR OXYGEN CYLINDER | Sep 19, 1984 | Substantially Equivalent |