FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HETERODYNAMIC
K Number: K821157
·
Decision Jun 23, 1982
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
27
Review Days
62
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Basic Information
- Device Name
- HETERODYNAMIC
- K Number
- K821157
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Birtcher Corp.
- Date Received
- April 22, 1982
- Decision Date
- June 23, 1982
- Product Code
- IPF
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | FDA class 2 | Physical Medicine |
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Other Clearances by Birtcher Corp.
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|---|---|---|---|
| K881328 | MODEL 375 ECG | May 18, 1988 | Substantially Equivalent |
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| 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 |
| K844101 | CARDIO-NEC MODEL 365 | Apr 9, 1985 | Substantially Equivalent |
| K844104 | CARDIO ANALYZER MODEL 380 | Mar 6, 1985 | Substantially Equivalent |
| K850297 | ELECTROSURGICAL PENCIL HOLDER 720 | Feb 28, 1985 | Substantially Equivalent |