510(k) K213087
- Device
- Natural Rubber Latex Ultrasound Transducer Probe Covers
- Applicant
- Global Protection Corp.
- 510(k) number
- K213087
- Product code
- ITX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-06-07
- Date received
- 2021-09-24
- Regulation
- 892.1570
- Classification name
- Transducer, Ultrasonic, Diagnostic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Christina Cataldo
- Address
- 12 Channel St. Boston MA US 02210 02210
FDA Registration Numbers
- 3033527241
- 1222780
- 3010258456
- 1000314502
- 1221485
- 3017233611
- 3003774756
- 3013058729
- 3014605202
- 3006441164
- 3004485675
- 3013844297
- 3015525240
- 3042225166
- 1066270
- 3011688715
- 3011416394
- 3010827261
- 3014574557
- 3015997711
- 3010400367
- 3012387143
- 1047843
- 3010102386
- 3009196578
- 3006161756
- 3012811961
- 3013041594
- 1225687
- 3027788423
- 3005403518
- 9611665
- 1220477
- 9610482
- 3015276088
- 3010273872
- 3008321254
- 3013429557
- 9616086
- 3005406110
- 3008386005
- 1055823
- 9611031
- 3042172882
- 3002619337
- 3002315840
- 1820334
- 3024673
- 3013515803
- 3014769442
- 3010952312
- 1226587
- 3030733800
- 3015194986
- 3003971136
- 3012104670
- 3011200896
- 3010381606
- 2938651
- 3006786907
- 3004727093
- 9611680
- 1528319
- 3032109181
- 3000126629
- 3010280625
- 2183319
- 3032109225
- 1054713
- 1037885
- 3010060157
- 3013462478
- 3008515880
- 3009529630
- 3005860720
- 2032350
- 3012747207
- 3001763079
- 3014432311
Source Documents
510(k) summary PDF not indicated by FDA
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