FDA 510(k)
Substantially Equivalent
🇺🇸 United States
ELITE ELECTROCARDIOGRAPH
K Number: K870920
·
Decision Apr 13, 1987
Classifications
0
FEI Numbers
11
Registration Numbers
11
Same Product Code
82
Applicant Total
38
Review Days
38
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Basic Information
- Device Name
- ELITE ELECTROCARDIOGRAPH
- K Number
- K870920
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Burdick Corp.
- Date Received
- March 6, 1987
- Decision Date
- April 13, 1987
- Product Code
- LOS
- Advisory Committee
- Unknown
- Review Advisory Committee
- CV
- Third Party
- N
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LOS), ordered by most recent decision date.
Other Clearances by Burdick Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K942565 | ALTAIR-DISC RECORDER | Dec 5, 1994 | Substantially Equivalent |
| K941351 | BURDICK PRO2 OXIMETER | Oct 13, 1994 | Substantially Equivalent |
| 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 |
| K885085 | ERGOMED 840/ERGOMED 840L | Oct 3, 1989 | 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 |
| K870880 | EK10 ELECTROCARDIOGRAPH | Apr 9, 1987 | Substantially Equivalent |