FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE BERMAN AND GUEDEL AIRWAYS
K Number: K861540
·
Decision May 2, 1986
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
56
Applicant Total
21
Review Days
8
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Basic Information
- Device Name
- DISPOSABLE BERMAN AND GUEDEL AIRWAYS
- K Number
- K861540
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5110
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Dryden Corp.
- Date Received
- April 24, 1986
- Decision Date
- May 2, 1986
- 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
FDA 510(k)
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Other Clearances by Dryden Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K880923 | PATIENT VENTILATOR ISOLATOR | Sep 6, 1988 | Substantially Equivalent |
| K880769 | BREATHING CIRCUIT W/HEATED WIRE | Aug 24, 1988 | Substantially Equivalent |
| K882285 | NONREBREATHING CIRCUIT | Aug 16, 1988 | Substantially Equivalent |
| K873928 | UNIVERSAL TOURNIQUET | Oct 23, 1987 | Substantially Equivalent |
| K873927 | REUSEABLE BREATHING TUBES | Oct 20, 1987 | Substantially Equivalent |
| K870859 | BAG-TAIL BLEED VALVE | Aug 3, 1987 | Substantially Equivalent |
| K871386 | BREATHING CIRCUIT | May 29, 1987 | Substantially Equivalent |
| K870858 | BADGWELL SAMPLING CATHETER | May 14, 1987 | Substantially Equivalent |
| K850644 | NASOPHARYNGEAL AIRWAY-ROBERTAZZI | Mar 21, 1985 | Substantially Equivalent |
| K842843 | DRYDEN SCAVENGER INTERFACE SYSTEM | Jul 27, 1984 | Substantially Equivalent |