FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC
K Number: K963377
·
Decision Oct 4, 1996
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
71
Applicant Total
3
Review Days
38
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
- EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC
- K Number
- K963377
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- North Eos Industries, Inc.
- Date Received
- August 27, 1996
- Decision Date
- October 4, 1996
- Product Code
- HIB
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HIB | Speculum, Vaginal, Nonmetal | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HIB), ordered by most recent decision date.
JFord Speculum Sleeve
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BRELLA-SPEC(TM) VAGINAL SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
IOB DISPOSABLE SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CLEARSPEC SINGLE USE VAGINAL SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SPECULUM, VAGINAL, NONMETAL
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
KOLPLUX SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology