FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOTRACHEAL TUBE W/HOLDER & CONNECTOR
K Number: K790312
·
Decision Feb 21, 1979
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
240
Applicant Total
27
Review Days
8
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Basic Information
- Device Name
- ENDOTRACHEAL TUBE W/HOLDER & CONNECTOR
- K Number
- K790312
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Respiratory Support Products, Inc.
- Date Received
- February 13, 1979
- Decision Date
- February 21, 1979
- Product Code
- BTR
- 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 |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | FDA class 2 | Anesthesiology |
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Other Clearances by Respiratory Support Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K983862 | CLOUD 1 HUMIDIFICATION SYSTEM | May 24, 1999 | Substantially Equivalent |
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| 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 |