FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDCO-SONIC NQ-2000
K Number: K860099
·
Decision Apr 9, 1986
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
88
Applicant Total
8
Review Days
89
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Basic Information
- Device Name
- MEDCO-SONIC NQ-2000
- K Number
- K860099
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5300
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Medco Products, Co., Inc.
- Date Received
- January 10, 1986
- Decision Date
- April 9, 1986
- 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 Medco Products, Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K932466 | MEDCHEM SURGICAL DELIVERY SYSTEM | Aug 9, 1993 | Substantially Equivalent |
| K913172 | ENDOSCOPIC DELIVERY SYSTEM | Sep 6, 1991 | Substantially Equivalent |
| K852015 | JYROCHAIR, MODEL SK-H | Jul 19, 1985 | Substantially Equivalent |
| K851659 | SKULL MOUNTED STEREOTACTIC SURGICAL DEVICE | Jul 1, 1985 | Substantially Equivalent |
| K844580 | MEDCOLATOR MODEL HVX | Feb 25, 1985 | Substantially Equivalent |
| K842712 | MEDCOLATOR MODEL GX | Sep 19, 1984 | Substantially Equivalent |
| K822829 | ROTARY VASCULAR KNIFE | Nov 17, 1982 | Substantially Equivalent |