FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
HV-4
K Number: K853154
·
Decision Mar 28, 1986
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
21
Review Days
242
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Basic Information
- Device Name
- HV-4
- K Number
- K853154
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Robert Bosch Corp.
- Date Received
- July 29, 1985
- Decision Date
- March 28, 1986
- 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 Robert Bosch Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K854493 | ERG 555 COUCH ERGOMETER | Jun 16, 1986 | Substantially Equivalent |
| K854491 | ERG 550 ERGOMETER BICYCLE | Jun 16, 1986 | Substantially Equivalent |
| K854492 | ERG 551 ERGOMETER, BICYCLE | Jun 16, 1986 | Substantially Equivalent |
| K853541 | SP 4 | Mar 28, 1986 | Substantially Equivalent for Some Indications |
| K853271 | HEARING AID ANALYSIS SYSTEM | Jan 16, 1986 | Substantially Equivalent |
| K851485 | DEFI 502 | Aug 29, 1985 | Substantially Equivalent |
| K840717 | ECS 502 | Aug 19, 1985 | Substantially Equivalent |
| K851937 | SONOMED 4 | Jul 17, 1985 | Substantially Equivalent |
| K850188 | BOSCH IN THE EAR HEARING AID SUPERSTAR | Apr 9, 1985 | Substantially Equivalent |
| K850186 | POST AURICULAR HEARING AIDS STAR 33PP, 44,55F & | Mar 27, 1985 | Substantially Equivalent |