FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BSD-200
K Number: K833158
·
Decision Mar 30, 1984
Classifications
1
FEI Numbers
488
Registration Numbers
488
Same Product Code
797
Applicant Total
3
Review Days
196
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BSD-200
- K Number
- K833158
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Bsd Medical Corp.
- Date Received
- September 16, 1983
- Decision Date
- March 30, 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 |
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)
FDA 510(k)
FDA Class 2
·General Hospital
Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)
FDA 510(k)
FDA Class 2
·General Hospital
Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)
FDA 510(k)
FDA Class 2
·General Hospital
Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)
FDA 510(k)
FDA Class 2
·General Hospital
YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
FDA 510(k)
FDA Class 2
·General Hospital
Infrared Thermometer
FDA 510(k)
FDA Class 2
·General Hospital