FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE TEMPERATURE PROBE
K Number: K770353
·
Decision Mar 16, 1977
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
20
Applicant Total
7
Review Days
22
Basic Information
- Device Name
- DISPOSABLE TEMPERATURE PROBE
- K Number
- K770353
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- INHAL-O-TECH MEDICAL PLASTIC
- Date Received
- February 22, 1977
- Decision Date
- March 16, 1977
- Product Code
- KPD
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KPD | Strip, Temperature, Forehead, Liquid Crystal | FDA class 2 | General Hospital |
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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 |
| K781395 | DISPOSABLE AEROSOL T BRIGGS ADAPTOR | Aug 31, 1978 | 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 |