FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PCM ANESTHESIA
K Number: K903991
·
Decision Feb 25, 1991
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
187
Applicant Total
6
Review Days
180
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Basic Information
- Device Name
- PCM ANESTHESIA
- K Number
- K903991
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5160
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Siemens Life Support Systems
- Date Received
- August 29, 1990
- Decision Date
- February 25, 1991
- 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 Siemens Life Support Systems
| K Number | Device Name | ||
|---|---|---|---|
| K902859 | SERVO VENTILATOR 300 | Apr 26, 1991 | Substantially Equivalent |
| K901474 | ANESTHESIA WORKSTATION | Apr 10, 1990 | Substantially Equivalent |
| K893786 | SERVO ANESTHESIA CIRCLE 985 | Sep 22, 1989 | Substantially Equivalent |
| K890932 | CAV 3.0C SOFTWARE PROGRAM | Jun 12, 1989 | Substantially Equivalent |
| K890921 | DATA EXCHANGE SYSTEM, MODEL 24 | Jun 8, 1989 | Substantially Equivalent |