FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HOLTER KIT MODEL #5000 SERIES
K Number: K823414
·
Decision Dec 30, 1982
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
193
Applicant Total
21
Review Days
45
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
- HOLTER KIT MODEL #5000 SERIES
- K Number
- K823414
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Andover Medical, Inc.
- Date Received
- November 15, 1982
- Decision Date
- December 30, 1982
- 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 Andover Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K905729 | CANMED 451 | Feb 7, 1991 | Substantially Equivalent |
| K903427 | NORTECH MODEL 86901000 ELECTRODE | Aug 17, 1990 | Substantially Equivalent |
| K885171 | MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE | Jan 12, 1989 | Substantially Equivalent |
| K860636 | FASTRACE III, ECG ELECTRODE | May 9, 1986 | Substantially Equivalent |
| K854433 | ECG MONITORING/DEFIBRILLATION ELECTRODE | May 8, 1986 | Substantially Equivalent |
| K860535 | UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS) | Apr 1, 1986 | Substantially Equivalent |
| K860283 | AMI CARDIO-PAD | Mar 31, 1986 | Substantially Equivalent |
| K843410 | FLOW-DIRECTED PEDIATRIC THERMODIL- CATH | Nov 20, 1984 | Substantially Equivalent |
| K843412 | FLOW DIRECTED THERMODILUTION CATH W/VEN | Nov 20, 1984 | Substantially Equivalent |
| K843411 | THERMAL DILUTION CATHETER | Oct 18, 1984 | Substantially Equivalent |