FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ERGOMED 840/ERGOMED 840L
K Number: K885085
·
Decision Oct 3, 1989
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
38
Review Days
298
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Basic Information
- Device Name
- ERGOMED 840/ERGOMED 840L
- K Number
- K885085
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Burdick Corp.
- Date Received
- December 9, 1988
- Decision Date
- October 3, 1989
- Product Code
- DRT
- 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 |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | FDA class 2 | Cardiovascular |
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Other Clearances by Burdick Corp.
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|---|---|---|---|
| K942565 | ALTAIR-DISC RECORDER | Dec 5, 1994 | Substantially Equivalent |
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| K904032 | ELITE II ELECTROCARDIOGRAPH | Jul 24, 1991 | Substantially Equivalent |
| K903565 | E560 ELECTROCARDIOGRAPH | Jul 24, 1991 | Substantially Equivalent |
| K900729 | NEOSERV 824 | Jun 8, 1990 | Substantially Equivalent |
| K892835 | E350 ELECTROCARDIOGRAPH | Jun 1, 1989 | Substantially Equivalent |
| K883440 | E550 ELECTROCARDIOGRAPH | Jan 17, 1989 | Substantially Equivalent |
| K873774 | M300 MONITOR/CONTROLLER T500 TREADMILL | Nov 6, 1987 | Substantially Equivalent |
| K870920 | ELITE ELECTROCARDIOGRAPH | Apr 13, 1987 | Substantially Equivalent |
| K870880 | EK10 ELECTROCARDIOGRAPH | Apr 9, 1987 | Substantially Equivalent |