FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RYUSEI
K Number: K772424
·
Decision May 9, 1978
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
2
Applicant Total
2
Review Days
132
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Basic Information
- Device Name
- RYUSEI
- K Number
- K772424
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5580
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Ercona Corp.
- Date Received
- December 28, 1977
- Decision Date
- May 9, 1978
- Product Code
- BWJ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| BWJ | Locator, Acupuncture Point | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BWJ), ordered by most recent decision date.
POINT LOCATOR STIMULATOR
FDA 510(k)
FDA Class 2
·General Hospital
PLS MINI
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Ercona Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K812387 | DIGITRON ELECTRONIC THERMOMETERS - 4700 | Sep 9, 1981 | Substantially Equivalent |