FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODEL 16800 TREND RECORDER
K Number: K821612
·
Decision Jul 14, 1982
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
86
Applicant Total
35
Review Days
42
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Basic Information
- Device Name
- MODEL 16800 TREND RECORDER
- K Number
- K821612
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.2810
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Healthdyne, Inc.
- Date Received
- June 2, 1982
- Decision Date
- July 14, 1982
- Product Code
- DSF
- 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 |
|---|---|---|---|
| DSF | Recorder, Paper Chart | FDA class 1 | Cardiovascular |
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| K903287 | MODEL 900S APNEA/HEART MONITOR | Aug 17, 1990 | Substantially Equivalent |
| K894030 | MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR | Jan 22, 1990 | Substantially Equivalent |
| K892006 | HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S | May 23, 1989 | Substantially Equivalent |