FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROSPAN -PH MONITOR
K Number: K842303
·
Decision Oct 12, 1984
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
68
Applicant Total
28
Review Days
123
Basic Information
- Device Name
- MICROSPAN -PH MONITOR
- K Number
- K842303
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5470
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- BIOCHEM INTERNATIONAL, INC.
- Date Received
- June 11, 1984
- Decision Date
- October 12, 1984
- Product Code
- CBF
- 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 |
|---|---|---|---|
| CBF | Chamber, Hyperbaric | FDA class 2 | Anesthesiology |
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|---|---|---|---|
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| 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 |