FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE AEROSOL T BRIGGS ADAPTOR
K Number: K781395
·
Decision Aug 31, 1978
Classifications
1
FEI Numbers
167
Registration Numbers
167
Same Product Code
93
Applicant Total
7
Review Days
17
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Basic Information
- Device Name
- DISPOSABLE AEROSOL T BRIGGS ADAPTOR
- K Number
- K781395
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Inhal-O-Tech Medical Plastic
- Date Received
- August 14, 1978
- Decision Date
- August 31, 1978
- Product Code
- BZA
- 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 |
|---|---|---|---|
| BZA | Connector, Airway (Extension) | FDA class 1 | Anesthesiology |
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Other Clearances by Inhal-O-Tech Medical Plastic
| K Number | Device Name | ||
|---|---|---|---|
| K781741 | MASK, BI FLO NASAL OXYGEN | Dec 1, 1978 | Substantially Equivalent |
| K781394 | DISPOSABLE INCENTIVE SPIROMETER | Oct 16, 1978 | Substantially Equivalent |
| K770353 | DISPOSABLE TEMPERATURE PROBE | Mar 16, 1977 | Substantially Equivalent |
| K770354 | TUBING, AEROSAL, DISPOSABLE | Mar 16, 1977 | Substantially Equivalent |
| K760329 | MASK, DISPOSABLE OXYGEN THERAPY | Sep 30, 1976 | Substantially Equivalent |
| K760330 | CANNULA, DISPOSABLE OXYGEN TTHERAPY | Aug 4, 1976 | Substantially Equivalent |