FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
ELC-THERMO-SYSTEM
K Number: K770678
·
Decision May 25, 1977
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
6
Applicant Total
39
Review Days
44
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Basic Information
- Device Name
- ELC-THERMO-SYSTEM
- K Number
- K770678
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 884.2982
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Cutter Laboratories, Inc.
- Date Received
- April 11, 1977
- Decision Date
- May 25, 1977
- Product Code
- KXZ
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| KXZ | System, Thermographic, Liquid Crystal, Powered (Adjunctive Use) | FDA class 3 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KXZ), ordered by most recent decision date.
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FLEXI-THERM FILM
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Other Clearances by Cutter Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K861315 | HYPERBARIC PENETRATION EXTENSION SET | May 21, 1986 | Substantially Equivalent |
| K854106 | BAYSILEX | Mar 17, 1986 | Substantially Equivalent |
| K842324 | PERFOURM | Nov 9, 1984 | Substantially Equivalent |
| K834106 | INTRAVENOUS INFUSION CONTROLLER | May 30, 1984 | Substantially Equivalent |
| K832237 | ORTHOPEDIC CASTING TAPE MAXCAST | Aug 16, 1983 | Substantially Equivalent |
| K823214 | DOSIMETRIC RELEASE PROGRAM - ADMIN. SET | Jan 12, 1983 | Substantially Equivalent |
| K821326 | CUTTER BOND POLYCARBOXYLATE CEMENT | May 28, 1982 | Substantially Equivalent |
| K813532 | CUTTERBOND ZINC PHOSPHATE CEMENT | Mar 2, 1982 | Substantially Equivalent |
| K802105 | C-BLADE | Sep 16, 1980 | Substantially Equivalent |
| K802104 | C-SPLINT | Sep 16, 1980 | Substantially Equivalent |