FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE MOUTHPIECE
K Number: K791537
·
Decision Sep 7, 1979
Classifications
1
FEI Numbers
162
Registration Numbers
162
Same Product Code
24
Applicant Total
27
Review Days
28
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Basic Information
- Device Name
- DISPOSABLE MOUTHPIECE
- K Number
- K791537
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5620
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Hospitak, Inc.
- Date Received
- August 10, 1979
- Decision Date
- September 7, 1979
- Product Code
- BYP
- 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 |
|---|---|---|---|
| BYP | Mouthpiece, Breathing | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYP), ordered by most recent decision date.
NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE
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TRUZONE PFM DISPOSABLE MOUTHPIECE
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BREATHING MOUTHPIECE
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AEROCHAMBER
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SAFE-T-SHIELD MOUTHPIECE
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INHALATION AID
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 |