FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYDRO/BUBBLE BATH DEVICE 300
K Number: K842641
·
Decision Jul 25, 1984
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
72
Applicant Total
3
Review Days
15
Basic Information
- Device Name
- HYDRO/BUBBLE BATH DEVICE 300
- K Number
- K842641
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5100
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- HEDDERNHEIMER METALLWARENFABRIK GMBH
- Date Received
- July 10, 1984
- Decision Date
- July 25, 1984
- Product Code
- ILJ
- 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 |
|---|---|---|---|
| ILJ | Bath, Hydro-Massage | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ILJ), ordered by most recent decision date.
PARKER 500
FDA 510(k)
FDA Class 2
·Physical Medicine
IMMERSION HYDROBATH
FDA 510(k)
FDA Class 2
·Physical Medicine
MBATH 1000 (60)
FDA 510(k)
FDA Class 2
·Physical Medicine
PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
SUPERIOR BATH, MODEL 6300
FDA 510(k)
FDA Class 2
·Physical Medicine
CASCADE BATH, MODEL 6900
FDA 510(k)
FDA Class 2
·Physical Medicine