FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUBMAX
K Number: K790644
·
Decision Apr 26, 1979
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
10
Review Days
27
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Basic Information
- Device Name
- SUBMAX
- K Number
- K790644
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Chase Mfg. Co.
- Date Received
- March 30, 1979
- Decision Date
- April 26, 1979
- Product Code
- DRT
- 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 |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | FDA class 2 | Cardiovascular |
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Other Clearances by Chase Mfg. Co.
| K Number | Device Name | ||
|---|---|---|---|
| K791513 | ADAMCO DUST COVER | Oct 11, 1979 | Substantially Equivalent |
| K790993 | INSTANT HOT & COLD PACKS | Sep 7, 1979 | Substantially Equivalent |
| K780033 | MATTRESSES, CONDUCTIVE & COVERS | Feb 21, 1978 | Substantially Equivalent |
| K771792 | ENEMA SET | Oct 20, 1977 | Substantially Equivalent |
| K771791 | NEEDLE COUNTING | Oct 4, 1977 | Substantially Equivalent |
| K770900 | CAST BRWM, FRACTURE | Jul 21, 1977 | Substantially Equivalent |
| K770898 | FRACTURE CAST BRACE KIT, PLASTIC | Jul 21, 1977 | Substantially Equivalent |
| K770899 | FRACTURE CAST BRACE, POLY | Jul 21, 1977 | Substantially Equivalent |
| K770173 | STOCKINETTE | Feb 8, 1977 | Substantially Equivalent |