FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RADIANT TEMPERATUR INDICATOR MODEL 25E
K Number: K903501
·
Decision Sep 12, 1990
Classifications
1
FEI Numbers
488
Registration Numbers
488
Same Product Code
797
Applicant Total
8
Review Days
40
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Basic Information
- Device Name
- RADIANT TEMPERATUR INDICATOR MODEL 25E
- K Number
- K903501
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Medical Systems Corp.
- Date Received
- August 3, 1990
- Decision Date
- September 12, 1990
- 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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YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
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Infrared Thermometer
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Other Clearances by Medical Systems Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K931736 | M-FLEX 5000 C3PMD | Jan 27, 1994 | Substantially Equivalent |
| K921513 | SPIROLITE MODEL MSC-201 SPIROMETER | Jan 27, 1993 | Substantially Equivalent |
| K921485 | LA MONT VIDEO PATIENT MONITORING SYSTEM | Oct 22, 1992 | Substantially Equivalent |
| K904353 | CARDIOMATIC MODEL MSC-2001 | Dec 20, 1990 | Substantially Equivalent |
| K902192 | MODEL MSC SA02-5000 PULSE OXIMETER | Aug 23, 1990 | Substantially Equivalent |
| K902608 | CARDIOMATIC MODEL MSC-1001 | Jul 13, 1990 | Substantially Equivalent |
| K770878 | SIGNAL PROCESSOR/AVERAGER MODEL 7S11 | Jun 1, 1977 | Substantially Equivalent |