FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RECTAL TEMP. TELEMETRY MONITOR
K Number: K832404
·
Decision Sep 12, 1983
Classifications
1
FEI Numbers
488
Registration Numbers
488
Same Product Code
797
Applicant Total
82
Review Days
54
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Basic Information
- Device Name
- RECTAL TEMP. TELEMETRY MONITOR
- K Number
- K832404
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Xomed, Inc.
- Date Received
- July 20, 1983
- Decision Date
- September 12, 1983
- 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
Other 510(k) clearances with the same product code (FLL), ordered by most recent decision date.
Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)
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Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)
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YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
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Infrared Thermometer
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Other Clearances by Xomed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K002395 | MODEL 30 CLASSIC PNEUMATONOMETER | Dec 11, 2000 | Substantially Equivalent |
| K002987 | REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE | Dec 4, 2000 | Substantially Equivalent |
| K002828 | XPS NITRO SYSTEM | Oct 17, 2000 | Substantially Equivalent |
| K002897 | TITANIUM MIDDLE EAR PROSTHESES | Oct 11, 2000 | Substantially Equivalent |
| K993653 | MICRO-FRANCE TROCARS AND ACCESSORIES | Jun 9, 2000 | Substantially Equivalent |
| K001148 | MEROGEL OTOLOGIC PACK | Jun 3, 2000 | Substantially Equivalent |
| K994262 | FRONTAL SINUS TREPHINATION CANNULA | Feb 8, 2000 | Substantially Equivalent |
| K992855 | XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT | Jan 21, 2000 | Substantially Equivalent |
| K993582 | MODIFICATION TO LASER-SHIELD II | Jan 20, 2000 | Substantially Equivalent |
| K993655 | MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS | Dec 21, 1999 | Substantially Equivalent |