FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPLASH ADAPTOR
K Number: K853665
·
Decision Oct 10, 1985
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
21
Applicant Total
1
Review Days
37
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
- SPLASH ADAPTOR
- K Number
- K853665
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5995
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Ohio Medical Research, Inc.
- Date Received
- September 3, 1985
- Decision Date
- October 10, 1985
- Product Code
- BYH
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BYH | Drain, Tee (Water Trap) | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYH), ordered by most recent decision date.
AQUALARM MOISTURE SENSOR MODEL P85000
FDA 510(k)
FDA Class 1
·Anesthesiology
CARIE MED-TECH MODEL 210 RAINOUT DRAINAGE SYSTEM
FDA 510(k)
FDA Class 1
·Anesthesiology
DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS
FDA 510(k)
FDA Class 1
·Anesthesiology
THAYER SUCTION EVACUATION CONDENSATE COLLECTION
FDA 510(k)
FDA Class 1
·Anesthesiology
THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM
FDA 510(k)
FDA Class 1
·Anesthesiology
THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM
FDA 510(k)
FDA Class 1
·Anesthesiology