FDA 510(k)
Substantially Equivalent
🇺🇸 United States
BI-TEMP TEMPERATURE MONITOR
K Number: K863987
·
Decision Nov 18, 1986
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
27
Review Days
35
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Basic Information
- Device Name
- BI-TEMP TEMPERATURE MONITOR
- K Number
- K863987
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Respiratory Support Products, Inc.
- Date Received
- October 14, 1986
- Decision Date
- November 18, 1986
- Advisory Committee
- Unknown
- Review Advisory Committee
- AN
- Third Party
- N
Other Clearances by Respiratory Support Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K983862 | CLOUD 1 HUMIDIFICATION SYSTEM | May 24, 1999 | Substantially Equivalent |
| K921190 | ADAP-TEMP TEMPERATURE SENSOR ADAPTER | Mar 9, 1993 | Substantially Equivalent |
| K920469 | MYOCARDINAL TEMPERATURE SENSOR WITH TYPE 400 SERIE | Sep 11, 1992 | Substantially Equivalent |
| K921510 | GAS SAMPLING KIT MODIFICATION | Jun 11, 1992 | Substantially Equivalent |
| K913082 | BI-TEMP TEMPERATURE MONITOR,MODEL TM-300D | Dec 11, 1991 | Substantially Equivalent |
| K913083 | BI-TEMP TEMPERATURE MONITOR TM-201D | Oct 17, 1991 | Substantially Equivalent |
| K912280 | BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D | Oct 17, 1991 | Substantially Equivalent |
| K903816 | URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR | Oct 31, 1990 | Unknown |
| K874694 | ADAP-TEMP, MODEL: AT-100 | Mar 1, 1988 | Substantially Equivalent |
| K873472 | MEMBRANE HUMIDIFIER | Jan 19, 1988 | Substantially Equivalent |