FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ETHYLENE OXIDE DETECTOR GLD-1-07
K Number: K834152
·
Decision Mar 19, 1984
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
183
Applicant Total
6
Review Days
109
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Basic Information
- Device Name
- ETHYLENE OXIDE DETECTOR GLD-1-07
- K Number
- K834152
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6880
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Calnor of EL Paseo, Inc.
- Date Received
- December 1, 1983
- Decision Date
- March 19, 1984
- Product Code
- FLE
- 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 |
|---|---|---|---|
| FLE | Sterilizer, Steam | FDA class 2 | General Hospital |
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Other Clearances by Calnor of EL Paseo, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K841895 | GSR, 126, EEG 130-TEMP. 132, EMG 133 | Jul 17, 1984 | Substantially Equivalent |
| K842353 | TEMPERATURE 132 | Jul 17, 1984 | Substantially Equivalent |
| K842288 | EEG 130 | Jul 17, 1984 | Substantially Equivalent |
| K842354 | EMG MODEL 133 | Jul 17, 1984 | Substantially Equivalent |
| K771577 | CLINICAL EMG MODEL 133 | Aug 26, 1977 | Substantially Equivalent |