FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEMAND OXYGEN CONSERVING DEVICE, DOCD, THE DOC
K Number: K983601
·
Decision Dec 15, 1998
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
70
Applicant Total
7
Review Days
62
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Basic Information
- Device Name
- DEMAND OXYGEN CONSERVING DEVICE, DOCD, THE DOC
- K Number
- K983601
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medical Electronic Devices, Inc.
- Date Received
- October 14, 1998
- Decision Date
- December 15, 1998
- Product Code
- NFB
- 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 |
|---|---|---|---|
| NFB | Conserver, Oxygen | FDA class 2 | Anesthesiology |
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Other Clearances by Medical Electronic Devices, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K052563 | INOGEN SATELLITE CONSERVER, MODEL SC-100 | Oct 24, 2005 | Substantially Equivalent |
| K033197 | INOGEN SATELLITE CONSERVER | May 13, 2004 | Substantially Equivalent |
| K023420 | PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB | Oct 25, 2002 | Substantially Equivalent |
| K983459 | PULSED OXYGEN CONSERVING DEVICE, POCD | Dec 8, 1998 | Substantially Equivalent |
| K770115 | ARTERIAL DIAGNOSTIC UNIT (ADU) | Feb 1, 1977 | Substantially Equivalent |
| K761092 | INGUINAL COMPRESSIVE DEVICE (ICD) | Dec 16, 1976 | Substantially Equivalent |