FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HMB-200
K Number: K800250
·
Decision Mar 25, 1980
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
64
Applicant Total
14
Review Days
48
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Basic Information
- Device Name
- HMB-200
- K Number
- K800250
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5975
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Associated Mills, Inc.
- Date Received
- February 6, 1980
- Decision Date
- March 25, 1980
- Product Code
- IRO
- 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 |
|---|---|---|---|
| IRO | Vibrator, Therapeutic | FDA class 1 | Physical Medicine |
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Other Clearances by Associated Mills, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K901459 | DS60 TOOTHBRUSH SANITIZER | Sep 17, 1990 | Substantially Equivalent |
| K872327 | WHIRLPOOL AERATOR WB700, WB800, WB900, WB975 | Sep 4, 1987 | Substantially Equivalent |
| K871661 | WH150 ROOM HUMIDIFIER | Jun 15, 1987 | Substantially Equivalent |
| K862041 | WM10, WM20, WM30 POWER MASSAGER | Jun 17, 1986 | Substantially Equivalent |
| K862042 | SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER | Jun 5, 1986 | Substantially Equivalent |
| K844396 | POLLENEX DIGITAL SPHYGMOMANOMETER BP-2000 | Apr 18, 1985 | Substantially Equivalent |
| K844397 | POLLENEX DIGITAL SPHYGMOMANOMETER BP-4000 | Apr 18, 1985 | Substantially Equivalent |
| K850363 | POLLENEX DIGITAL THERMOMETER T-225 | Feb 15, 1985 | Substantially Equivalent |
| K850362 | POLLENEX DIGITAL THERMOMETER T-125 | Feb 15, 1985 | Substantially Equivalent |
| K841095 | BP800, 850 1000 | Aug 24, 1984 | Substantially Equivalent |