FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPIRO SCAN
K Number: K851135
·
Decision Jul 1, 1985
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
227
Applicant Total
21
Review Days
102
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
- SPIRO SCAN
- K Number
- K851135
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1840
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Brentwood Instruments, Inc.
- Date Received
- March 21, 1985
- Decision Date
- July 1, 1985
- Product Code
- BZG
- 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 |
|---|---|---|---|
| BZG | Spirometer, Diagnostic | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZG), ordered by most recent decision date.
MESI mTABLET SPIRO
FDA 510(k)
FDA Class 2
·Anesthesiology
TD-7301 Spirometer (TD-7301)
FDA 510(k)
FDA Class 2
·Anesthesiology
Air Next (NVD-02)
FDA 510(k)
FDA Class 2
·Anesthesiology
Spirobank Oxi
FDA 510(k)
FDA Class 2
·Anesthesiology
EasyOne Sky Spirometer
FDA 510(k)
FDA Class 2
·Anesthesiology
Alveoair Digital Spirometer
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Brentwood Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K896924 | SPIROSCAN 4000 | Mar 1, 1990 | Substantially Equivalent |
| K882366 | RHYTHMSCAN HR HOLTER RECORDER | Aug 2, 1988 | Substantially Equivalent |
| K871572 | RHYTHMSCAN | Feb 22, 1988 | Substantially Equivalent |
| K860024 | FUKUDA DENSHI CARDIMAX FCP-211 | Mar 31, 1986 | Substantially Equivalent |
| K853979 | CARDIMAX FX-1164 | Feb 6, 1986 | Substantially Equivalent |
| K854505 | CARDIMAX FX-406U | Feb 4, 1986 | Substantially Equivalent |
| K851124 | T-1000 ECG TRANSMITTER | May 15, 1985 | Substantially Equivalent |
| K851123 | R-1000 ECG RECEIVER | May 15, 1985 | Substantially Equivalent |
| K842976 | BRENTWOOD EZ SCAN 200 AMBULATORY ECG | Mar 1, 1985 | Substantially Equivalent |
| K844470 | FUKUDA DENSHI MODEL FCP-220 | Jan 10, 1985 | Substantially Equivalent |