FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLOCARE
K Number: K893875
·
Decision Aug 11, 1989
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
72
Applicant Total
1
Review Days
77
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
- FLOCARE
- K Number
- K893875
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Mega-Tech Intl., Inc.
- Date Received
- May 26, 1989
- Decision Date
- August 11, 1989
- Product Code
- BYD
- 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 |
|---|---|---|---|
| BYD | Condenser, Heat And Moisture (Artificial Nose) | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYD), ordered by most recent decision date.
HEAT & MOISTURE EXCHANGER
FDA 510(k)
FDA Class 1
·Anesthesiology
DISPOSABLE HME/FILTER
FDA 510(k)
FDA Class 1
·Anesthesiology
HEAT MOISTURE EXCHANGER
FDA 510(k)
FDA Class 1
·Anesthesiology
TYPE 1 & 2 (HUMIDAIR I & II)
FDA 510(k)
FDA Class 1
·Anesthesiology
HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT
FDA 510(k)
FDA Class 1
·Anesthesiology
HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE
FDA 510(k)
FDA Class 1
·Anesthesiology