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#
- 3004116007
- 3010865451
- 3045857735
- 3012392312
- 2032476
- 3017642731
- 3009278376
- 1832066
- 3009955851
- 1834244
- 3009056001
- 3014165708
- 9710603
- 3014680784
- 3029875292
- 3044519507
- 3008630266
- 3043460907
- 1034116
- 3039346864
- 3018117722
- 3008775647
- 3016914692
- 3042970964
- 3003770834
- 3007005431
- 3030266256
- 1836161
- 3033790380
- 1528695
- 3007798904
- 9616144
- 3010409218
- 3011776382
- 3031595580
- 2428983
- 3017486514
- 3012316249
- 3001124136
- 1417592
- 1831750
- 8030607
- 1218386
- 3006803543
- 3009560848
- 3014674312
- 3002798200
- 2182536
- 3014220748
- 3007048057
- 1043644
- 3003641560
- 9616471
- 1043615
- 1836047
- 3010579827
- 3007734888
- 1531186
- 3014256531
- 3015286905
- 3036470679
- 3009525805
- 3015423385
- 3013545943
- 3009008046
- 3009327812
- 3017375560
- 3029836575
- 3004082002
- 3021907521
- 3009488612
- 3011529836
- 1226711
- 1320918
- 8022590
- 1824206
- 3006365764
- 3009591865
- 3018115503
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 |