FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FACE TENTS
K Number: K781055
·
Decision Jul 17, 1978
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
54
Applicant Total
27
Review Days
24
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Basic Information
- Device Name
- FACE TENTS
- K Number
- K781055
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5580
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Hospitak, Inc.
- Date Received
- June 23, 1978
- Decision Date
- July 17, 1978
- Product Code
- BYG
- 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 |
|---|---|---|---|
| BYG | Mask, Oxygen | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYG), ordered by most recent decision date.
FIRST AID KIT(S)
FDA 510(k)
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·Anesthesiology
HANS RUDOLPH NASAL CPAP MASK
FDA 510(k)
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DISPOSABLE, CPAP OXYGEN MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS
FDA 510(k)
FDA Class 1
·Anesthesiology
WESTMED PEDIATRIC AND ADULT AEROSOL MASK
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 |