510(k) K970334

Device
NATURE'S CRADLE
Applicant
INFANT ADVANTAGE, INC.
510(k) number
K970334
Product code
FMS  
Decision
Substantially Equivalent (SESE)
Decision date
1997-04-25
Date received
1997-01-28
Regulation
880.5140
Classification name
Bed, Pediatric Open Hospital
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
GERALD V BEEMILLER
Address
2000 Crow Canyon Pl., Suite 185 San Ramon CA US 94583 94583

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FMS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K963210VAIL 100 PEDIATRIC CRIBVail Products, Inc.1996-11-13
K960747NATURE'S CRADLE MODEL C1500Infant Advantage, Inc.1996-05-22
K960012STRYKER ADEL BASSINETStryker Corp.1996-03-25
K951024NATURE'S CRADLEInfant Advantage, Inc.1995-06-05
K950059MC INFANT CARE UNIE #PP30Janco Consulting Services1995-02-10
K950058MC HEALTHCARE #CH31 CHILD'S CRIBJanco Consulting Services1995-02-10
K950051BREWER COMPANY TEDDY CRIB MODEL 71900-A, B, 71910-A, BThe Brewer Co.1995-02-10
K925530INSTRUMENT WARMERSuperior Healthcare Group, Inc.1993-06-18
K925949PEDICRAGT BASSINETPedicraft, Inc.1993-04-20
K925817HEAD & FOOT END DROP PEDI-CRIBPedicraft, Inc.1993-04-20
K921327NATURE'S CRADLE HM-10Infant Advantage, Inc.1992-12-29
K901763NATURE'S CRADLE(TM)Infant Advantage, Inc.1991-03-22
K900873PEDIATRIC HOSPITAL BEDHospital Supply Co., Inc.1990-05-18
K883818MODIFIED REFLUX REDUCERPhysician Engineered Products, Inc.1988-11-21
K881019BABYROCKERCinventa AB1988-06-07

Legacy Summary#

summary

FDA Review#

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