FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ALARM SYS FOR NITROUS OXIDE SYS.
K Number: K771246
·
Decision Jul 15, 1977
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
12
Applicant Total
5
Review Days
4
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Basic Information
- Device Name
- ALARM SYS FOR NITROUS OXIDE SYS.
- K Number
- K771246
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.2700
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Star Dental Mfg. Co.
- Date Received
- July 11, 1977
- Decision Date
- July 15, 1977
- Product Code
- ECX
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| ECX | Cylinder, Compressed Gas, And Valve | FDA class 1 | Anesthesiology |
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Other Clearances by Star Dental Mfg. Co.
| K Number | Device Name | ||
|---|---|---|---|
| K905155 | HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECES | Feb 13, 1991 | Substantially Equivalent |
| K782007 | ROTARY SCALER | Jan 3, 1979 | Substantially Equivalent |
| K781281 | CEMENT, DENTAL/CAVITY LINER | Aug 21, 1978 | Substantially Equivalent |
| K771247 | CORE MATERIAL | Jul 15, 1977 | Substantially Equivalent |