FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
#400 BROOK AIRWAY & #900 PROFESSIONAL BROOK AIRWAY
K Number: K883593
·
Decision Sep 30, 1988
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
56
Applicant Total
7
Review Days
38
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Basic Information
- Device Name
- #400 BROOK AIRWAY & #900 PROFESSIONAL BROOK AIRWAY
- K Number
- K883593
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5110
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Ecolab, Inc.
- Date Received
- August 23, 1988
- Decision Date
- September 30, 1988
- 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
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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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RUSCH OPTOSAFE
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