SPIROVISION
FDA 510(k) clearance K864885 · decided 1987-01-15
Clearance details
- K-number
- K864885
- Device name
- SPIROVISION
- Applicant
- Futuremed Div. of Future Impex Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-12-12
- Decision date
- 1987-01-15
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- BZM
- Device class
- 2
- Regulation number
- 868.1900
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Deerpark, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PULMOTRACK 2020 SYSTEM (K102229) | Karmelsonix | 2011-03-04 |
| PERSONAL WHEEZOMETER (K090863) | Karmelsonix | 2009-09-21 |
| WIM-PC, MODEL 1010 (K071955) | Karmelsonix | 2007-11-01 |
| STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM (K012387) | Stethographics, Inc. | 2002-04-23 |
| PULMOTRACK,MODEL 1010 (K980878) | Karmel Medical Acoustic Technologies , Ltd. | 1998-12-28 |
| ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM (K974200) | Orca Diagnostics Corp. | 1998-07-21 |
| CPX, CCM, CATH WITH 15% CO2 (K955432) | Medical Graphics Corp. | 1996-07-01 |
| MEDGRAPHICS EXERCISE CONSULT (K923209) | Medical Graphics Corp. | 1993-03-11 |
| PB100 DIAGNOSTIC SPIROMETER (K911143) | Puritan Bennett Corp. | 1991-11-29 |
| EXERCISE EVALUATION SYSTEM 2010 (K896345) | Medical Graphics Corp. | 1990-01-20 |
| BURROWS-KNUDSON AUTOMATED LUNG FUNCTION INTER. SYS (K880550) | Medimicro Systems, Inc. | 1988-07-25 |
| SINGLE BREATH LUNG DIFFUS TEST DEVICE SPIROMETERY (K874902) | Gomi Medical Instruments | 1988-06-07 |
Recalls involving this device
No recalls on record reference this clearance.