FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEART RATE & TEMP. MEASUREMENT SYSTEM
K Number: K822939
·
Decision Nov 24, 1982
Classifications
1
FEI Numbers
488
Registration Numbers
488
Same Product Code
797
Applicant Total
18
Review Days
51
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Basic Information
- Device Name
- HEART RATE & TEMP. MEASUREMENT SYSTEM
- K Number
- K822939
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Camino Laboratories, Inc.
- Date Received
- October 4, 1982
- Decision Date
- November 24, 1982
- 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 |
Similar 510(k) Clearances
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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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Other Clearances by Camino Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K932769 | CAMINO VENTRICULAR DRAINAGE SYSTEM | Mar 30, 1995 | Substantially Equivalent |
| K930222 | CAMINO VENTRICULAR ACCESS DEVICE | Apr 15, 1993 | Substantially Equivalent |
| K930221 | CAMINO VENTRICULAR TRANSDUCER ACCESSORY | Apr 15, 1993 | Substantially Equivalent |
| K920088 | CAMINO VENTRICULAR NEEDLE | May 1, 1992 | Substantially Equivalent |
| K914735 | VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM | Jan 17, 1992 | Substantially Equivalent |
| K912833 | CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAY | Sep 23, 1991 | Substantially Equivalent |
| K893232 | MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM | Jul 14, 1989 | Substantially Equivalent |
| K881183 | VENTRICULAR BOLT PRESSURE MONITORING KIT #110-4H | May 4, 1988 | Substantially Equivalent |
| K863969 | CAMINO COMPARTMENTAL PRESS MONITOR CATH/110-4D | May 27, 1987 | Substantially Equivalent |
| K861961 | CAMINO CSF DRAINAGE SYSTEM MODEL 040 | Aug 12, 1986 | Substantially Equivalent |