ADEL MODEL 2100 BIRTHING BED
FDA 510(k) clearance K874610 · decided 1988-01-21
Clearance details
- K-number
- K874610
- Device name
- ADEL MODEL 2100 BIRTHING BED
- Applicant
- Adel Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1987-11-09
- Decision date
- 1988-01-21
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- HDD
- Device class
- 2
- Regulation number
- 884.4900
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Clackamas, OR, 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 |
|---|---|---|
| ADEL 5000 (K950889) | Stryker Corp. | 1995-10-16 |
| THE GENESIS BED FROM HILL-ROM, MODEL 355 SERIES (K914309) | Hill-Rom, Inc. | 1992-04-20 |
| ORCEPAD (K875123) | Alton Dean Medical, Inc. | 1988-06-21 |
| ADEL MEDICAL BIRTHING BED, #LD-500 (K810886) | Adel Medical , Ltd. | 1981-04-23 |
| TILT 10, CATALOG #S-2600 (K771942) | Affiliated Hospital Products, Inc. | 1977-10-27 |
| CART, PROCEDURES (K770438) | I E Industries | 1977-07-01 |
Recalls involving this device
No recalls on record reference this clearance.