FDA 510(k)
Substantially Equivalent
🇺🇸 United States
MODEL P-8 PROFESSIONAL
K Number: K811114
·
Decision Nov 23, 1981
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
16
Review Days
214
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MODEL P-8 PROFESSIONAL
- K Number
- K811114
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Bloomex International, Inc.
- Date Received
- April 23, 1981
- Decision Date
- November 23, 1981
- Advisory Committee
- Unknown
- Review Advisory Committee
- PM
- Third Party
- N
Other Clearances by Bloomex International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943185 | BX-200 SC | Aug 14, 1995 | Substantially Equivalent for Some Indications |
| K942195 | BX-400S | Aug 14, 1995 | Substantially Equivalent for Some Indications |
| K842142 | BX-400 | Jun 25, 1984 | Substantially Equivalent |
| K841779 | ELECTRONIC MUSCLE EXERCISE EQUIPMENT | May 30, 1984 | Substantially Equivalent |
| K832976 | BX-600 EMS | Nov 25, 1983 | Substantially Equivalent |
| K822287 | BX-500 ELECTRONIC MUSCLE EXERCISER | Oct 13, 1982 | Substantially Equivalent |
| K821110 | ELECTRONIC MUSCLE EXERCISER | Jul 1, 1982 | Substantially Equivalent |
| K820080 | BX-1000 ISOMATIC | Jul 1, 1982 | Substantially Equivalent |
| K813410 | BX-400 JESSE JIMBODY | Mar 8, 1982 | Substantially Equivalent |
| K813443 | BX-400 SPORT | Mar 8, 1982 | Substantially Equivalent |