FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEFI 502
K Number: K851485
·
Decision Aug 29, 1985
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
165
Applicant Total
21
Review Days
136
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Basic Information
- Device Name
- DEFI 502
- K Number
- K851485
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Robert Bosch Corp.
- Date Received
- April 15, 1985
- Decision Date
- August 29, 1985
- Product Code
- LDD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | FDA class 2 | Cardiovascular |
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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 |
| K853154 | HV-4 | Mar 28, 1986 | Substantially Equivalent for Some Indications |
| K853271 | HEARING AID ANALYSIS SYSTEM | Jan 16, 1986 | 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 |