FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIO-NEC MODEL 365
K Number: K844101
·
Decision Apr 9, 1985
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
27
Review Days
168
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Basic Information
- Device Name
- CARDIO-NEC MODEL 365
- K Number
- K844101
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Birtcher Corp.
- Date Received
- October 23, 1984
- Decision Date
- April 9, 1985
- Product Code
- DPS
- 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 |
|---|---|---|---|
| DPS | Electrocardiograph | FDA class 2 | Cardiovascular |
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Other Clearances by Birtcher Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K881328 | MODEL 375 ECG | May 18, 1988 | Substantially Equivalent |
| K860718 | ELECTROSURGERY PENCIL, MODEL 767 | Mar 24, 1986 | Substantially Equivalent |
| K860687 | BIRT-A-SWITCH, DSP PUSH BUTTON, MODEL NO. 768 | Mar 24, 1986 | Substantially Equivalent |
| K854814 | SURGICAL CAUTERIES MODELS 775-11,12,13,31,32 & 33 | Jan 13, 1986 | Substantially Equivalent |
| K854864 | BI-POLAR FORCEPS | Dec 24, 1985 | Substantially Equivalent |
| K850668 | ELECTROSURGICAL UNIT 774 | May 20, 1985 | Substantially Equivalent |
| K850943 | MODEL 775 BIPOLAR COAGULATOR | May 20, 1985 | Substantially Equivalent |
| K844104 | CARDIO ANALYZER MODEL 380 | Mar 6, 1985 | Substantially Equivalent |
| K850297 | ELECTROSURGICAL PENCIL HOLDER 720 | Feb 28, 1985 | Substantially Equivalent |
| K844103 | CARDIOPAC DEFIBRILLATOR 444 | Jan 18, 1985 | Substantially Equivalent |