FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THERMOCOUPLE ADAPTER
K Number: K873833
·
Decision Nov 3, 1987
Classifications
1
FEI Numbers
488
Registration Numbers
488
Same Product Code
797
Applicant Total
92
Review Days
43
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Basic Information
- Device Name
- THERMOCOUPLE ADAPTER
- K Number
- K873833
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Mallinckrodt Critical Care
- Date Received
- September 21, 1987
- Decision Date
- November 3, 1987
- Product Code
- FLL
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | FDA class 2 | General Hospital |
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Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)
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Infrared Thermometer
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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 |
| 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 |
| K862653 | LUER LOCK ADAPTER/NUT | Jul 31, 1986 | Substantially Equivalent |