FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTROCARDIOGRAPH
K Number: K852181
·
Decision Oct 9, 1985
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
5
Review Days
142
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Basic Information
- Device Name
- ELECTROCARDIOGRAPH
- K Number
- K852181
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Armstrong Ind., Inc.
- Date Received
- May 20, 1985
- Decision Date
- October 9, 1985
- Product Code
- DPS
- 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 |
|---|---|---|---|
| DPS | Electrocardiograph | FDA class 2 | Cardiovascular |
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Other Clearances by Armstrong Ind., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K852281 | SCHILLER EKG COMBI MSG-IM SCOPE & RECORDER | Oct 9, 1985 | Substantially Equivalent |
| K852282 | SCHILLER MINISCOPE MS-2 EKG SCOPE | Oct 9, 1985 | Substantially Equivalent |
| K851705 | LARYNGOSCOPE | May 21, 1985 | Substantially Equivalent |
| K822727 | RESCUER | Sep 28, 1982 | Substantially Equivalent |