ECHOCARDIOGRAPHY
FDA 510(k) clearance K945163 · decided 1995-02-17
Clearance details
- K-number
- K945163
- Device name
- ECHOCARDIOGRAPHY
- Applicant
- Tri W-G, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-10-21
- Decision date
- 1995-02-17
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- LGX
- Device class
- 1
- Regulation number
- 878.4960
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Valley City, ND, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Tri W-G
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 |
|---|---|---|
| POWER EXAMINATION TABLE MODEL # 411 (K894134) | Midmark Corp. | 1989-08-28 |
| POWER EXAMINATION TABLE MODEL # 405 (K894144) | Midmark Corp. | 1989-08-28 |
| MEDALIST EXAMINATION TABLE (K883680) | Hamilton Industries, Inc. | 1988-10-04 |
| POWER EXAMINATION TABLE (K882010) | Enochs Mfg., Inc. | 1988-07-13 |
| ADEC 1005-C CHAIR (K864072) | Cherne Industries, Inc. | 1986-11-07 |
| RELIANCE MODEL 200 PODIATRY CHAIR (K860519) | F. & F. Koenigkramer | 1986-02-19 |
| STORZ PLASTIC SURGERY & EXAMINATION LOUNGE 7000 (K845023) | Storz Instrument Co. | 1985-01-28 |
| MEDICAL EXAM TABLE (K830294) | Coe Laboratories, Inc. | 1984-01-11 |
| S & W SW52E W/POWER BACK LIFT (K832768) | S & W Enterprises, Inc. | 1983-09-20 |
| MULTIPLE, MODEL #17 (K820823) | Midmark Corp. | 1982-04-21 |
| SMR PARAGON CHAIR TABLE (K811623) | Smr | 1981-07-02 |
| THREE MODELS OF TABLES, STOOLS, & LIGHTS (K811190) | Midmark Corp. | 1981-05-08 |
Recalls involving this device
No recalls on record reference this clearance.