FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PULSE OXIMETER
K Number: K862426
·
Decision Sep 11, 1986
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
10
Applicant Total
78
Review Days
77
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Basic Information
- Device Name
- PULSE OXIMETER
- K Number
- K862426
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2710
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Draeger Medical, Inc.
- Date Received
- June 26, 1986
- Decision Date
- September 11, 1986
- Product Code
- DPZ
- Advisory Committee
- Cardiovascular
- 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 |
|---|---|---|---|
| DPZ | Oximeter, Ear | FDA class 2 | Cardiovascular |
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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 |