CORE MONITORING SYSTEM-SP1475/6275/5607/5708/4575
FDA 510(k) clearance K921727 · decided 1994-05-10
Clearance details
- K-number
- K921727
- Device name
- CORE MONITORING SYSTEM-SP1475/6275/5607/5708/4575
- Applicant
- Viggo-Spectramed
- Decision
- Substantially Equivalent
- Date received
- 1992-04-10
- Decision date
- 1994-05-10
- Days to decision
- 760 days
- Clearance type
- Traditional
- Product code
- KNF
- Device class
- 2
- Regulation number
- 884.4160
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Oxnard, CA, US
- Third-party review
- No
- Expedited review
- No
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| Sonata Transcervical Fibroid Ablation System 2.2 (K211535) | Gynesonics, Inc. | 2021-06-17 |
| Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 (K193516) | Gynesonics, Inc. | 2020-05-04 |
| Sonata Sonography-Guided Transcervical Fibroid Ablation System (K173703) | Gynesonics, Inc. | 2018-08-15 |
| LINA GOLD LOOP HC (K132135) | Lina Medical Aps | 2014-01-31 |
| MODULAP LOOP (K121343) | Atc Technologies, Inc. | 2013-06-14 |
| JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS (K103726) | Integra LifeSciences Corporation | 2012-02-08 |
| LAP LOOP (K092897) | Medsys, S.A. | 2010-02-01 |
| LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 (K070315) | Lina Medical Aps | 2007-10-30 |
Recalls involving this device
No recalls on record reference this clearance.