Submission Details
| 510(k) Number | K872327 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 17, 1987 |
| Decision Date | September 04, 1987 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
K872327 is an FDA 510(k) clearance for the WHIRLPOOL AERATOR WB700, WB800, WB900, WB975, a Bath, Hydro-massage (Class II — Special Controls, product code ILJ), submitted by Associated Mills, Inc. (Chicago, US). The FDA issued a Cleared decision on September 4, 1987, 79 days after receiving the submission on June 17, 1987. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5100.
| 510(k) Number | K872327 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 17, 1987 |
| Decision Date | September 04, 1987 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | ILJ — Bath, Hydro-massage |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 890.5100 |