FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEO-FLOAT NEONATAL FLOTATION SYS & RHYT
K Number: K832829
·
Decision Oct 4, 1983
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
56
Applicant Total
3
Review Days
46
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
- NEO-FLOAT NEONATAL FLOTATION SYS & RHYT
- K Number
- K832829
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5170
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Clinical Data Instruments, Inc.
- Date Received
- August 19, 1983
- Decision Date
- October 4, 1983
- Product Code
- IOQ
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IOQ | Bed, Flotation Therapy, Powered | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IOQ), ordered by most recent decision date.
Hill-Rom Wireless Connectivity Module
FDA 510(k)
FDA Class 2
·Physical Medicine
TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2
FDA 510(k)
FDA Class 2
·Physical Medicine
NURSE'S AID PATIENT ROTATION SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
HYDROTEC LOW AIR LOSS THERAPY BED
FDA 510(k)
FDA Class 2
·Physical Medicine
AIRTEC2 LOW AIR LOSS THERAPY BED
FDA 510(k)
FDA Class 2
·Physical Medicine
TOTALCARE., MODULAR THERAPY SYSTEM (MTS)
FDA 510(k)
FDA Class 2
·Physical Medicine