510(k) K772062
- Device
- NEONATAL FLOTATION SYSTEM
- Applicant
- Medpro, Inc.
- 510(k) number
- K772062
- Product code
- IKY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-11-15
- Date received
- 1977-11-02
- Regulation
- 880.5150
- Classification name
- Mattress, Flotation Therapy, Non-Powered
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- 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#
- 3002668219
- 3007378235
- 1528759
- 3007309299
- 3006802326
- 1824206
- 3004194020
- 3013685983
- 1528695
- 3036470679
- 3012643605
- 3010526655
- 3005484027
- 2428983
- 3007582653
- 3008058231
- 3007734888
- 3014165708
- 3033506545
- 3004116007
- 9616144
- 3017642731
- 3009560848
- 3008541934
- 3012316249
- 3009591865
- 2435947
- 3012392312
- 3017171467
- 3018117722
- 3033790380
- 3014680784
- 3006697241
- 3032252823
- 3005179379
- 3011537487
- 8030607
- 3021907521
- 1226711
- 3035224824
- 3008791328
- 3029875292
- 1034116
- 3007798904
- 3011529836
- 3014579161
- 3009683397
- 3010409218
- 1041130
- 3009008046
- 3018101346
- 3024761165
- 1419181
- 8043965
- 3006803543
- 3010515377
- 1531186
- 3035380696
- 3030266256
- 1836047
- 2182536
- 2529695
- 3006554931
- 3013528589
- 3010865451
- 1834244
- 3011776382
- 3009327812
- 3008630266
- 3007005431
- 1832066
- 3003770834
- 3007008421
- 3017375560
- 1831750
- 1043644
- 3018084435
- 3004824601
- 3011191255
- 3006365764
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IKY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K914921 | SCM-3 AND ACCESSORIES | Gaymar Industries, Inc. | 1992-03-12 |
| K813226 | GEL FLOTATION MATTRESS | Jefferson Industries, Inc. | 1981-12-02 |
| K802781 | BEDDING PADS EGGCREATE PADS | Leemart Bedding Mfg. Co. | 1980-12-10 |
| K802833 | TETRA NATAL-MAT WATER FLOTATION MAT. | Tetra Group U.S.A., Inc. | 1980-12-10 |
| K780779 | ECONO-FLOAT WATER FLOTATION MATTRESS | Jefferson Industries, Inc. | 1978-05-19 |
| K771824 | MEDPRO FLOTATION SYSTEM | Medpro, Inc. | 1977-10-19 |
| K760963 | DECUBITUS MATTRESS | Arco Medical Products Co. | 1976-11-18 |