510(k) K841687
- Device
- SKYNDEX ELECTRONIC BODY FAT CALCULA
- Applicant
- CALDWELL, JUSTISS & CO., INC.
- 510(k) number
- K841687
- Product code
- KTZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-06-28
- Date received
- 1984-04-23
- Regulation
- 888.4150
- Classification name
- Caliper
- Medical specialty
- Orthopedic
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2432177
- 3006215390
- 3015876273
- 3005031160
- 9614069
- 3009790163
- 1421101
- 3009760038
- 2027467
- 1834379
- 3008572101
- 8010697
- 1030489
- 3007441485
- 3004464325
- 3012725451
- 1226544
- 3010531060
- 3013846070
- 3011600579
- 1645151
- 3016050940
- 3008902714
- 3009973505
- 8040278
- 3013552516
- 3005061536
- 3010388970
- 3015542154
- 3019356409
- 1221763
- 3004176895
- 3012447612
- 1066741
- 9681642
- 3009513193
- 1923569
- 1816267
- 3003120897
- 8010379
- 3011499367
- 1020279
- 3006513362
- 1419489
- 3000270450
- 9680002
- 1219655
- 3046310097
- 1822565
- 3007773213
- 3009888740
- 3035366890
- 3005739886
- 1421879
- 3005325790
- 3003407244
- 3022320321
- 9611112
- 9614093
- 3010455030
- 3003597504
- 3001297506
- 3005809810
- 3017410889
- 3021666757
- 3005677016
- 3015895045
- 9611579
- 3015512299
- 3017264244
- 3019878714
- 1422507
- 3010536692
- 3038187464
- 3017521423
- 3010097171
- 9610621
- 3015259876
- 9610612
- 3034676720
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KTZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K921266 | NK MEDICAL MICROMETER, MODEL MC001 | Nk Biotechnical Engineering Co. | 1992-07-14 |
| K831898 | SCOLIMETER | Dr. Micheal A. Sabia | 1983-07-19 |
| K820659 | A CALIPER | Twin City Surgical, Inc. | 1982-03-19 |
| K810116 | ISOROBIC SKINFOLD CALIPER | Fitness Motivation Institute of America | 1981-02-04 |
| K800363 | PARKE-DAVIS TOTAL KNEE PROSTHESIS | Warner-Lambert Co. | 1980-03-10 |
| K760521 | TAPE MEASURE | Mcgaw Laboratories | 1976-11-12 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases