FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANESTHESIA APPARATUS PH-35
K Number: K830159
·
Decision Mar 9, 1983
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
187
Applicant Total
6
Review Days
55
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Basic Information
- Device Name
- ANESTHESIA APPARATUS PH-35
- K Number
- K830159
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5160
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- W.E. Leder Enterprises, Inc.
- Date Received
- January 13, 1983
- Decision Date
- March 9, 1983
- Product Code
- BSZ
- 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 |
|---|---|---|---|
| BSZ | Gas-Machine, Anesthesia | FDA class 2 | 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 |
| K831981 | LARYNGESCOPE | Sep 29, 1983 | Substantially Equivalent |
| K831878 | CARDIO-SCOPE MINI MONITOR | Sep 29, 1983 | Substantially Equivalent |
| K830161 | ANESTHESIA APATATUS #D-25 | Mar 9, 1983 | Substantially Equivalent |
| K830160 | ANESTHESIA APPARATUS #FO 20S | Mar 9, 1983 | Substantially Equivalent |