FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FOAM NOSE
K Number: K840399
·
Decision Mar 16, 1984
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
72
Applicant Total
92
Review Days
46
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Basic Information
- Device Name
- FOAM NOSE
- K Number
- K840399
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Mallinckrodt Critical Care
- Date Received
- January 30, 1984
- Decision Date
- March 16, 1984
- Product Code
- BYD
- 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 |
|---|---|---|---|
| BYD | Condenser, Heat And Moisture (Artificial Nose) | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYD), ordered by most recent decision date.
HEAT & MOISTURE EXCHANGER
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DISPOSABLE HME/FILTER
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TYPE 1 & 2 (HUMIDAIR I & II)
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HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT
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HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE
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Other Clearances by Mallinckrodt Critical Care
| K Number | Device Name | ||
|---|---|---|---|
| K880343 | BURNEY GALLBLADDER CATHETER KIT | May 1, 1989 | Substantially Equivalent |
| K874605 | HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR | Feb 2, 1988 | Substantially Equivalent |
| K874514 | HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE | Jan 29, 1988 | Substantially Equivalent |
| K874568 | HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR | Jan 6, 1988 | Substantially Equivalent |
| K874404 | HI-LO TEMP(R) SKIN TEMPERATURE SENSOR | Nov 6, 1987 | Substantially Equivalent |
| K873461 | LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) | Nov 6, 1987 | Substantially Equivalent |
| K873833 | THERMOCOUPLE ADAPTER | Nov 3, 1987 | Substantially Equivalent |
| K873004 | GUIDING CATHETER | Sep 15, 1987 | Substantially Equivalent |
| K871204 | CUFFED TRACHEAL TUBE (MULTIPLE) | Apr 21, 1987 | Substantially Equivalent |
| K862666 | UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE) | Aug 1, 1986 | Substantially Equivalent |