FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPIROMETRIC COMPUTER #SC-10
K Number: K802928
·
Decision Dec 17, 1980
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
89
Applicant Total
32
Review Days
28
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SPIROMETRIC COMPUTER #SC-10
- K Number
- K802928
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1880
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Cavitron Corp.
- Date Received
- November 19, 1980
- Decision Date
- December 17, 1980
- Product Code
- BZC
- 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 |
|---|---|---|---|
| BZC | Calculator, Pulmonary Function Data | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZC), ordered by most recent decision date.
STS
FDA 510(k)
FDA Class 2
·Anesthesiology
Vyntus/SentrySuite Product Line
FDA 510(k)
FDA Class 2
·Anesthesiology
Vyntus BODY
FDA 510(k)
FDA Class 2
·Anesthesiology
Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART
FDA 510(k)
FDA Class 2
·Anesthesiology
COSMED K5 Wearable Metabolic Technology
FDA 510(k)
FDA Class 2
·Anesthesiology
MiniBox +
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Cavitron Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K811582 | THE PLACER | Jul 28, 1981 | Substantially Equivalent |
| K810207 | MINOR SURGERY LIGHT | Feb 13, 1981 | Substantially Equivalent |
| K801623 | CAVITRON ULTRASONIC SURG. ASPIR. CUSA | Nov 18, 1980 | Substantially Equivalent |
| K801877 | SLIT LAMP ATTACHMENT | Sep 16, 1980 | Substantially Equivalent |
| K800869 | MODEL PM-20(N)(R)CO2 PATIENT MONITOR/ALA | May 28, 1980 | Substantially Equivalent |
| K800722 | AUTO-FIELD D AUTOMATED VISUAL DETECTOR | Apr 29, 1980 | Substantially Equivalent |
| K791585 | MODEL G-61 ULTRASONIC DENTAL UNIT | Sep 19, 1979 | Substantially Equivalent |
| K791277 | MODEL 6500 EXTRACTION IRRIGATION SYS | Aug 22, 1979 | Substantially Equivalent |
| K782054 | LASER, CO2 SURGICAL | Jan 17, 1979 | Substantially Equivalent |
| K782065 | LASER, PHOTOCOAGULATION | Dec 28, 1978 | Substantially Equivalent |