FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LARYNGESCOPE
K Number: K831981
·
Decision Sep 29, 1983
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
63
Applicant Total
6
Review Days
101
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Basic Information
- Device Name
- LARYNGESCOPE
- K Number
- K831981
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5540
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- W.E. Leder Enterprises, Inc.
- Date Received
- June 20, 1983
- Decision Date
- September 29, 1983
- Product Code
- CCW
- 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 |
|---|---|---|---|
| CCW | Laryngoscope, Rigid | FDA class 1 | Anesthesiology |
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Other Clearances by W.E. Leder Enterprises, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K831877 | ARF 850 E | Nov 3, 1983 | Substantially Equivalent |
| K831878 | CARDIO-SCOPE MINI MONITOR | Sep 29, 1983 | Substantially Equivalent |
| K830161 | ANESTHESIA APATATUS #D-25 | Mar 9, 1983 | Substantially Equivalent |
| K830159 | ANESTHESIA APPARATUS PH-35 | Mar 9, 1983 | Substantially Equivalent |
| K830160 | ANESTHESIA APPARATUS #FO 20S | Mar 9, 1983 | Substantially Equivalent |