FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MONITOR, SENSOMATIII OXYGEN
K Number: K781910
·
Decision Dec 26, 1978
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
46
Applicant Total
28
Review Days
42
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MONITOR, SENSOMATIII OXYGEN
- K Number
- K781910
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2500
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Biochem International, Inc.
- Date Received
- November 14, 1978
- Decision Date
- December 26, 1978
- Product Code
- KLK
- 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 |
|---|---|---|---|
| KLK | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KLK), ordered by most recent decision date.
MICROGAS 7650 TRANSCUTANEOUS MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
MICROGAS 7650 TRANSCUTANEOUS MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
SIEMENS SC9000/SC9015 TCP02/C02 MODULE
FDA 510(k)
FDA Class 2
·Anesthesiology
SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE
FDA 510(k)
FDA Class 2
·Anesthesiology
OXYCARE(TM) OXYGEN CONTROLLER/MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE
FDA 510(k)
FDA Class 2
·Anesthesiology
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 |
| K920082 | BIOCHEM MODEL 3301 NEWOX1 OXIMETER | Jan 7, 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 |