VERA 103
FDA 510(k) clearance K897143 · decided 1990-04-27
Clearance details
- K-number
- K897143
- Device name
- VERA 103
- Applicant
- Madsen North America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-12-27
- Decision date
- 1990-04-27
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- LYN
- Device class
- 2
- Regulation number
- 874.1050
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- North Tonawanda, 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 |
|---|---|---|
| SENSICARE SYNTHETIC, SURGICAL GLOVE LINER (K950995) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-06-28 |
| VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV (K880259) | Colorado Hearing Systems, Inc. | 1989-04-03 |
Recalls involving this device
No recalls on record reference this clearance.