FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
8100 ANESTHETIC AGENT MONITOR
K Number: K932389
·
Decision Dec 3, 1993
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
16
Applicant Total
28
Review Days
200
Basic Information
- Device Name
- 8100 ANESTHETIC AGENT MONITOR
- K Number
- K932389
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1620
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- BIOCHEM INTERNATIONAL, INC.
- Date Received
- May 17, 1993
- Decision Date
- December 3, 1993
- Product Code
- CBS
- 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 |
|---|---|---|---|
| CBS | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | FDA class 2 | Anesthesiology |
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Other Clearances by BIOCHEM INTERNATIONAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K920083 | BIOCHEM MODEL 3302 NEWOX2 OXIMETER | Apr 11, 1994 | Substantially Equivalent |
| K921388 | BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE | May 26, 1993 | Substantially Equivalent |
| K920082 | BIOCHEM MODEL 3301 NEWOX1 OXIMETER | Jan 7, 1993 | Substantially Equivalent |
| K911351 | BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP | Aug 22, 1991 | Substantially Equivalent |
| K910381 | BIOCHEM TEMPERATURE/ FIO2 MODULE | Aug 22, 1991 | Substantially Equivalent |
| K903222 | BIOCHEM 6100 NON-INVASIVE MONITOR | Sep 4, 1990 | Substantially Equivalent |
| K901861 | BIOCHEM 9100 MULTIGAS MONITOR | Jul 27, 1990 | Substantially Equivalent |
| K893877 | BIOCHEM 3100 OXIMETER | Dec 20, 1989 | Substantially Equivalent |
| K892646 | BIOCHEM 8100 ANESTHETIC AGENT MONITOR | Aug 31, 1989 | Substantially Equivalent |
| K890874 | BIOCHEM 520 BREATH INDICATOR | Jun 15, 1989 | Substantially Equivalent |