FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AIRWAYS
K Number: K780601
·
Decision May 19, 1978
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
56
Applicant Total
127
Review Days
39
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Basic Information
- Device Name
- AIRWAYS
- K Number
- K780601
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5110
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Abco Dealers, Inc.
- Date Received
- April 10, 1978
- Decision Date
- May 19, 1978
- 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
FDA 510(k)
FDA Class 1
·Anesthesiology
KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305
FDA 510(k)
FDA Class 1
·Anesthesiology
KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205
FDA 510(k)
FDA Class 1
·Anesthesiology
KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105
FDA 510(k)
FDA Class 1
·Anesthesiology
CUFFED OROPHARYNGEAL AIRWAY (COPA)
FDA 510(k)
FDA Class 1
·Anesthesiology
RUSCH OPTOSAFE
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Abco Dealers, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K905025 | DIGITAL THERMOMETER KITS | Feb 7, 1991 | Substantially Equivalent |
| K882304 | DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL) | Jul 12, 1988 | Substantially Equivalent |
| K880892 | BLOOD COLLECTING NEEDLE AND HOLDERS | Apr 21, 1988 | Substantially Equivalent |
| K880894 | ALLERGIST SYRINGES | Mar 31, 1988 | Substantially Equivalent |
| K872875 | STRETCH GAUZE BANDAGES | Sep 4, 1987 | Substantially Equivalent |
| K872874 | MICROSCOPE COVER GLASSES | Aug 10, 1987 | Substantially Equivalent |
| K872797 | NON-SKID SHOE COVERS | Aug 4, 1987 | Substantially Equivalent |
| K871465 | THERMOMETER SHEATHS | May 11, 1987 | Substantially Equivalent |
| K862726 | DISPOSABLE SHOE COVERS AND NURSES CAPS | Aug 1, 1986 | Substantially Equivalent |
| K862111 | ARMBOARDS, REUSABLE AND DISPOSABLE | Jul 8, 1986 | Substantially Equivalent |