FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOCHEM MODEL 3301 NEWOX1 OXIMETER
K Number: K920082
·
Decision Jan 7, 1993
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
28
Review Days
366
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Basic Information
- Device Name
- BIOCHEM MODEL 3301 NEWOX1 OXIMETER
- K Number
- K920082
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biochem International, Inc.
- Date Received
- January 7, 1992
- Decision Date
- January 7, 1993
- Product Code
- DQA
- Advisory Committee
- Cardiovascular
- 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 |
|---|---|---|---|
| DQA | Oximeter | FDA class 2 | Cardiovascular |
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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 |
| K932389 | 8100 ANESTHETIC AGENT MONITOR | Dec 3, 1993 | Substantially Equivalent |
| K921388 | BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE | May 26, 1993 | Substantially Equivalent |
| K910381 | BIOCHEM TEMPERATURE/ FIO2 MODULE | Aug 22, 1991 | Substantially Equivalent |
| K911351 | BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP | 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 |