WIM-PC, MODEL 1010
FDA 510(k) clearance K071955 · decided 2007-11-01
Clearance details
- K-number
- K071955
- Device name
- WIM-PC, MODEL 1010
- Applicant
- Karmelsonix
- Decision
- Substantially Equivalent
- Date received
- 2007-07-16
- Decision date
- 2007-11-01
- Days to decision
- 108 days
- Clearance type
- Special
- Product code
- BZM
- Device class
- 2
- Regulation number
- 868.1900
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Binyamina, IL
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Karmelsonix
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| 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 |
| MEDICAL GRAPHICS DESKTOP DIAGNOSTIC SYSTEM (K871711) | Medical Graphics Corp. | 1987-09-25 |
Recalls involving this device
No recalls on record reference this clearance.