FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EASY BREATHER MODEL 100
K Number: K893213
·
Decision Aug 4, 1989
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
20
Applicant Total
4
Review Days
99
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
- EASY BREATHER MODEL 100
- K Number
- K893213
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5935
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Progressive Productions , Ltd.
- Date Received
- April 27, 1989
- Decision Date
- August 4, 1989
- Product Code
- BYT
- 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 |
|---|---|---|---|
| BYT | Ventilator, External Body, Negative Pressure, Adult (Cuirass) | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYT), ordered by most recent decision date.
RTX RESPIRATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS
FDA 510(k)
FDA Class 2
·Anesthesiology
HAYEK OSCILLATOR(TM)
FDA 510(k)
FDA Class 2
·Anesthesiology
NEV-10 NEGATIVE PRESSURE VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM
FDA 510(k)
FDA Class 2
·Anesthesiology