Atlas FDA

OBSTETRICAL SAFETY SYSTEM

FDA 510(k) clearance K884868 · decided 1989-03-01

Clearance details

K-number
K884868
Device name
OBSTETRICAL SAFETY SYSTEM
Applicant
Buckman Co., Inc.
Decision
Substantially Equivalent
Date received
1988-11-21
Decision date
1989-03-01
Days to decision
100 days
Clearance type
Traditional
Product code
KNC
Device class
2
Regulation number
884.4900
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Martinez, CA, 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.

RecordFirmDate
L720 EXAMINATION CHAIR (K001261)Luneau Gynecologie SA2000-06-08
NON-LINTING DELIVERY BLANKET (K932035)Amsco Sterile Recoveries, Inc.1994-05-26
MEDICAL DISPOSABLE BEDDING (K924420)Hill-Rom, Inc.1993-12-10
BD6000 THE OPTIMA & BD5000 BIRTHING BED (K914544)Lic Care, Inc.1993-11-24
AFFINITY BED MODEL 3600 SERIES (K915779)Hill-Rom, Inc.1993-02-24
GARDOSI BIRTHING CUSHION (K903973)Graphic Controls Corp.1990-09-27
STRYKER MODEL 977 BIRTHING BED (K870745)Stryker Corp.1987-02-27
PALMER OBSTETRIC BRACE (K864194)Ad-Tech Medical Instrument Corp1987-01-14
MERIVAARA OBSTETRIC CHAIR/BED-MODEL 358 (K862931)Global Medical Prods, Inc.1986-08-07
LABOR-DELIVERY STRETCH/BED (K861030)Adel Medical , Ltd.1986-04-23
MERIVAARA OBSTETRIC CHAIR/BED MODEL 358 (K852174)Daun International, Inc.1985-09-06
CAT. NO. S-5300-E BIRTHING BED (K852171)Shampaine/Wilson1985-08-30

Recalls involving this device

No recalls on record reference this clearance.