CART, PROCEDURES
FDA 510(k) clearance K770438 · decided 1977-07-01
Clearance details
- K-number
- K770438
- Device name
- CART, PROCEDURES
- Applicant
- I E Industries
- Decision
- Substantially Equivalent
- Date received
- 1977-03-07
- Decision date
- 1977-07-01
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- HDD
- Device class
- 2
- Regulation number
- 884.4900
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch I E Industries
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 |
|---|---|---|
| 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 MODEL 2100 BIRTHING BED (K874610) | Adel Medical , Ltd. | 1988-01-21 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.