FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100
K Number: K062119
·
Decision Sep 22, 2006
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
44
Applicant Total
1
Review Days
59
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
- HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100
- K Number
- K062119
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.5200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medical Products Mfg., LLC
- Date Received
- July 25, 2006
- Decision Date
- September 22, 2006
- Product Code
- DRM
- 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 |
|---|---|---|---|
| DRM | Compressor, Cardiac, External | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRM), ordered by most recent decision date.
AutoPulse NXT Resuscitation System
FDA 510(k)
FDA Class 2
·Cardiovascular
RMU-2000 Automated Chest Compression System
FDA 510(k)
FDA Class 2
·Cardiovascular
LUCAS 3 Chest Compression System
FDA 510(k)
FDA Class 2
·Cardiovascular
LUCAS 3 Chest Compression System
FDA 510(k)
FDA Class 2
·Cardiovascular
ROSC-U Mini Chest Compressor (RMCC)
FDA 510(k)
FDA Class 2
·Cardiovascular
RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular