FDA 510(k)
Substantially Equivalent
🇺🇸 United States
ECLIPSE 4 ELECTROCARDIOGRAPH
K Number: K946281
·
Decision Apr 23, 1996
Classifications
0
FEI Numbers
11
Registration Numbers
11
Same Product Code
82
Applicant Total
6
Review Days
483
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
- ECLIPSE 4 ELECTROCARDIOGRAPH
- K Number
- K946281
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Burdick, Inc.
- Date Received
- December 27, 1994
- Decision Date
- April 23, 1996
- 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, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K952417 | QUEST EXERCISE STRESS SYSTEM | May 22, 1996 | Substantially Equivalent |
| K954267 | BURDICK 200 PULSE OXIMETER | May 3, 1996 | Substantially Equivalent |
| K945985 | PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400 | Jul 3, 1995 | Substantially Equivalent |
| K943959 | ECLIPSE 4 ELECTROCARDIOGRAPH | May 17, 1995 | Substantially Equivalent |
| K942438 | ALTAIR 6100 CASSETTE RECORDER | Aug 5, 1994 | Substantially Equivalent |