FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TYCOS SELF-CHECK/DIGITAL FEVER THERMO
K Number: K842132
·
Decision Jul 18, 1984
Classifications
1
FEI Numbers
488
Registration Numbers
488
Same Product Code
797
Applicant Total
37
Review Days
49
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Basic Information
- Device Name
- TYCOS SELF-CHECK/DIGITAL FEVER THERMO
- K Number
- K842132
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Sybron Corp.
- Date Received
- May 30, 1984
- Decision Date
- July 18, 1984
- 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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Other Clearances by Sybron Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K862284 | SEALITE | Jun 23, 1986 | Substantially Equivalent |
| K854855 | PROOF ALGINATE IMPRESSION MATERIAL | Jan 30, 1986 | Substantially Equivalent |
| K844092 | DIAGNOSTIC MICROSOPCE SLIDES | Oct 25, 1984 | Substantially Equivalent |
| K841910 | KERR SEALAPEX ROOT CANAL SEALER | Jul 13, 1984 | Substantially Equivalent |
| K841732 | LIEBEL-FLARSHEIM AFC 1000 X-RAY FILM | Jun 5, 1984 | Substantially Equivalent |
| K840469 | TYCOS SELF CHECK BPM3 BLOOD PRESS MONI | May 21, 1984 | Substantially Equivalent |
| K840407 | KERR RESIN BONDED BRIDGE CEMENT | May 21, 1984 | Substantially Equivalent |
| K840607 | LF MOTORIZED RADIOGRAPHIC FILM VIEWER | Mar 5, 1984 | Substantially Equivalent |
| K833138 | DIGITAL INJECTOR SYS | Nov 14, 1983 | Substantially Equivalent |
| K823795 | EVERBOND GLASS IONOMER CEMENT | Jan 26, 1983 | Substantially Equivalent |