FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
7CM BERMAN AIRWAY
K Number: K820512
·
Decision Mar 26, 1982
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
56
Applicant Total
75
Review Days
29
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Basic Information
- Device Name
- 7CM BERMAN AIRWAY
- K Number
- K820512
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5110
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Vital Signs, Inc.
- Date Received
- February 25, 1982
- Decision Date
- March 26, 1982
- Product Code
- CAE
- 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 |
|---|---|---|---|
| CAE | Airway, Oropharyngeal, Anesthesiology | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAE), ordered by most recent decision date.
LMA FAMILY OF AIRWAYS
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KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305
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KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205
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KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105
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FDA Class 1
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CUFFED OROPHARYNGEAL AIRWAY (COPA)
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RUSCH OPTOSAFE
FDA 510(k)
FDA Class 1
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| K990412 | CUFF-ABLE PLUS | Sep 1, 1999 | Substantially Equivalent |