MAXI-SCOPE OR ULTRA-SCOPE
FDA 510(k) clearance K912128 · decided 1991-06-28
Clearance details
- K-number
- K912128
- Device name
- MAXI-SCOPE OR ULTRA-SCOPE
- Applicant
- Seiichi Mfg., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-05-14
- Decision date
- 1991-06-28
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- LDE
- Device class
- 1
- Regulation number
- 870.1875
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Jamestown, KY, 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 |
|---|---|---|
| CYPRESS MEDICAL PRODUCTS STETHOSCOPE (K945082) | Cypress Medical Products, Ltd. | 1994-12-08 |
| VARIOUS STETHOSCOPES (K944337) | Rud Riester GmbH & CO KG | 1994-11-30 |
| MANUAL STETOSCOPE (K940578) | Bhs Intl., Inc. | 1994-04-26 |
| PROSCOPES AND ADSCOPES (K935944) | American Diagnostic Corp. | 1994-03-03 |
| STETHOSCOPE COVER (K923327) | Anup Chakraborty Co. | 1992-11-03 |
| TIMEOSCOPE AND FLEXISCOPE (K924095) | Stethoscopes of America, Inc. | 1992-10-20 |
| STETHOSCOPE (K914100) | Atlas Medical Products, Inc. | 1991-11-07 |
| VARIOUS TYPES OF STETHOSCOPES (K905487) | Liaoning-Usa Corp. | 1991-04-09 |
| STETHOSCOPE (K904547) | Kimball Industries Co., Ltd. | 1991-03-21 |
| V*S*R(TM) SCOPE (K895545) | Vsr Enterprises Corp. | 1989-11-15 |
| KAMED STETHOSCOPE (K890126) | D.R.G. | 1989-04-21 |
| STETH-SHIELD ACCESSORY TO A STETHOSCOPE (K882324) | Steth-Shield, Inc. | 1988-07-18 |
Recalls involving this device
No recalls on record reference this clearance.