FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALTAIR 6100 CASSETTE RECORDER
K Number: K942438
·
Decision Aug 5, 1994
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
193
Applicant Total
6
Review Days
77
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
- ALTAIR 6100 CASSETTE RECORDER
- K Number
- K942438
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Burdick, Inc.
- Date Received
- May 20, 1994
- Decision Date
- August 5, 1994
- Product Code
- DSH
- 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 |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DSH), ordered by most recent decision date.
Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)
FDA 510(k)
FDA Class 2
·Cardiovascular
VitaloJAK Clinic (Model 7100)
FDA 510(k)
FDA Class 2
·Cardiovascular
Zio® monitor (DFG0001)
FDA 510(k)
FDA Class 2
·Cardiovascular
AeviceMD
FDA 510(k)
FDA Class 2
·Cardiovascular
AT-Patch (ATP-C130/ATP-C70)
FDA 510(k)
FDA Class 2
·Cardiovascular
HiCardi+ H100
FDA 510(k)
FDA Class 2
·Cardiovascular
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 |
| K946281 | ECLIPSE 4 ELECTROCARDIOGRAPH | Apr 23, 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 |