FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE, HYPERBARIC OXYGEN CHAMBER
K Number: K840817
·
Decision Apr 25, 1984
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
22
Applicant Total
27
Review Days
61
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Basic Information
- Device Name
- DISPOSABLE, HYPERBARIC OXYGEN CHAMBER
- K Number
- K840817
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5650
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Hospitak, Inc.
- Date Received
- February 24, 1984
- Decision Date
- April 25, 1984
- Product Code
- KPJ
- 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 |
|---|---|---|---|
| KPJ | Chamber, Oxygen, Topical, Extremity | FDA class 2 | General, Plastic Surgery |
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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 |