FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DRAGER ORMC
K Number: K800764
·
Decision Apr 29, 1980
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
54
Applicant Total
78
Review Days
22
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
- DRAGER ORMC
- K Number
- K800764
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5330
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Draeger Medical, Inc.
- Date Received
- April 7, 1980
- Decision Date
- April 29, 1980
- Product Code
- BZR
- 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 |
|---|---|---|---|
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZR), ordered by most recent decision date.
F&P Optiflow Air/Oxygen Flow Source
FDA 510(k)
FDA Class 2
·Anesthesiology
Midas Flowmeter; eAVS
FDA 510(k)
FDA Class 2
·Anesthesiology
Maxtec MaxBlend2+p
FDA 510(k)
FDA Class 2
·Anesthesiology
FlowStar Analog Mixer Flowmeter
FDA 510(k)
FDA Class 2
·Anesthesiology
FlowStar Touch Digital Mixer Flowmeter
FDA 510(k)
FDA Class 2
·Anesthesiology
Quality Mix Blender, Oxymixer
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Draeger Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K042607 | PRIMUS US | Nov 26, 2004 | Substantially Equivalent |
| K042419 | FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM | Oct 8, 2004 | Substantially Equivalent |
| K042276 | D-VAPOR | Sep 23, 2004 | Substantially Equivalent |
| K042086 | FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM | Aug 31, 2004 | Substantially Equivalent |
| K041622 | MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM | Jul 8, 2004 | Substantially Equivalent |
| K040847 | MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR | Jun 17, 2004 | Substantially Equivalent |
| K033498 | NARKOMED 6400, MODEL NM6400 | Apr 26, 2004 | Substantially Equivalent |
| K030624 | MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM | Mar 17, 2004 | Substantially Equivalent |
| K031400 | FABIUS TIRO ANESTHESIA SYSTEM | Jul 15, 2003 | Substantially Equivalent |
| K022031 | NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2 | Aug 29, 2002 | Substantially Equivalent |