MODIFIED SONAMET BODY COMPOSITION ANALYZER
FDA 510(k) clearance K032610 · decided 2004-03-01
Clearance details
- K-number
- K032610
- Device name
- MODIFIED SONAMET BODY COMPOSITION ANALYZER
- Applicant
- Life Measurement, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-08-25
- Decision date
- 2004-03-01
- Days to decision
- 189 days
- Clearance type
- Abbreviated
- Product code
- OAC
- Device class
- 2
- Regulation number
- 870.2770
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Los Altos, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Life Measurement
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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 |
|---|---|---|
| BOD POD (K060848) | Life Measurement, Inc. | 2006-06-27 |
| SONAMET BODY COMPOSITION ANALYZER (K924972) | Life Measurement Instruments, Inc. | 1995-02-13 |
Recalls involving this device
No recalls on record reference this clearance.