FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEGASON MODEL 150
K Number: K843221
·
Decision Aug 24, 1984
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
88
Applicant Total
27
Review Days
8
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Basic Information
- Device Name
- MEGASON MODEL 150
- K Number
- K843221
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5300
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Birtcher Corp.
- Date Received
- August 16, 1984
- Decision Date
- August 24, 1984
- Product Code
- IMI
- 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 |
|---|---|---|---|
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
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Other Clearances by Birtcher Corp.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |