FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
PENNINE GUEDEL AIRWAY 00,0,1,2,3 & 4
K Number: K844873
·
Decision Feb 21, 1985
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
56
Applicant Total
8
Review Days
66
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Basic Information
- Device Name
- PENNINE GUEDEL AIRWAY 00,0,1,2,3 & 4
- K Number
- K844873
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5110
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Pennine Medical , Ltd.
- Date Received
- December 17, 1984
- Decision Date
- February 21, 1985
- 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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CUFFED OROPHARYNGEAL AIRWAY (COPA)
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RUSCH OPTOSAFE
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Other Clearances by Pennine Medical , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K854443 | O'NEIL URINARY CATHETER INTRODUCER | Jan 8, 1986 | Substantially Equivalent |
| K852859 | PENNINE CONNECTING TUBING | Jul 30, 1985 | Substantially Equivalent |
| K852081 | PENNINE OXYGEN LINK TUBING | Jun 14, 1985 | Substantially Equivalent |
| K844874 | PENNINE LINK YANKAUERS | Jun 6, 1985 | Substantially Equivalent |
| K844876 | PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16, | Jun 5, 1985 | Substantially Equivalent |
| K852079 | PENNINE DERBY YANKAUER | Jun 3, 1985 | Substantially Equivalent |
| K852080 | PENNINE SUCTION CATHETERS | Jun 3, 1985 | Substantially Equivalent |