FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BOMED-EEA
K Number: K853705
·
Decision Jan 13, 1986
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
328
Applicant Total
8
Review Days
131
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Basic Information
- Device Name
- BOMED-EEA
- K Number
- K853705
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Bomed Medical Mfr., Ltd.
- Date Received
- September 4, 1985
- Decision Date
- January 13, 1986
- Product Code
- DRX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | FDA class 2 | Cardiovascular |
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Other Clearances by Bomed Medical Mfr., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K853706 | BOMED-CDM | Apr 14, 1986 | Substantially Equivalent |
| K831422 | BIOFLOW | Sep 12, 1983 | Substantially Equivalent |
| K831421 | BOMED BIOCON | Sep 12, 1983 | Substantially Equivalent |
| K830792 | PULSETTE 110 TRANSCUTANEOUS ELEC-NERVE | Mar 29, 1983 | Substantially Equivalent |
| K813020 | BOMED-NCCOM | Dec 14, 1981 | Substantially Equivalent |
| K811999 | BO MED BIA | Aug 31, 1981 | Substantially Equivalent |
| K810064 | PULSARII, HIGH VOLT. GALVANIC MUSC. STIM | Jan 26, 1981 | Substantially Equivalent |