FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARTERIAL DIAGNOSTIC UNIT (ADU)
K Number: K770115
·
Decision Feb 1, 1977
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
136
Applicant Total
7
Review Days
13
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Basic Information
- Device Name
- ARTERIAL DIAGNOSTIC UNIT (ADU)
- K Number
- K770115
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Medical Electronic Devices, Inc.
- Date Received
- January 19, 1977
- Decision Date
- February 1, 1977
- Product Code
- DPW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | FDA class 2 | Cardiovascular |
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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 |
| K983601 | DEMAND OXYGEN CONSERVING DEVICE, DOCD, THE DOC | Dec 15, 1998 | Substantially Equivalent |
| K983459 | PULSED OXYGEN CONSERVING DEVICE, POCD | Dec 8, 1998 | Substantially Equivalent |
| K761092 | INGUINAL COMPRESSIVE DEVICE (ICD) | Dec 16, 1976 | Substantially Equivalent |